Anesthesiology
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- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent2Product Code
- EZXMesh, Surgical, Metal2Product Code
- MIBElastomer, Silicone Block2Product Code
- MICImplant, Muscle, Pectoralis2Product Code
- BTXBoard, Arm (With Cover), Sterile1Product Code
- FTLMesh, Surgical, Polymeric2Product Code
- FTMMesh, Surgical2Product Code
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- FYIAppliance, Facial Fracture, External1Product Code
- FZDProsthesis, Ear, Internal2Product Code
- FZEProsthesis, Nose, Internal2Product Code
- FZFSplint, Extremity, Inflatable, External1Product Code
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive1Product Code
- GBJProsthesis, Adhesive, External1Product Code
- JCQProsthesis, Esophagus2Product Code
- KCZProsthesis, Breast, External, Used With Adhesive1Product Code
- KDAProsthesis, Ptfe/Carbon-Fiber2Product Code
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2Product Code
- LZKImplant, Malar2Product Code
- MCATape, Surgical, Internal2Product Code
- MNFImplant, Temporal2Product Code
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1Product Code
- NODBoard, Arm (With Cover), Non-Sterile1Product Code
- NOJProsthesis, Breast, External, No Adhesive1Product Code
- NOKMaterial, External Aesthetic Restoration, No Adhesive1Product Code
- NWAProsthesis, Tracheal, Preformed/Molded2Product Code
- NYTProsthesis, Tracheal, Expandable, Polymeric2Product Code
- ODUFacial Implant2Product Code
- OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery2Product Code
- OODSurgical Film2Product Code
- OQLMesh, Surgical, Deployment Balloon2Product Code
- ORQMesh, Surgical, Deployer2Product Code
- OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery2Product Code
- OWSMesh, Surgical, Collagen, Plastics, Facial Implants2Product Code
- OWTMesh, Surgical, Absorbable, Abdominal Hernia2Product Code
- OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia2Product Code
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia2Product Code
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction2Product Code
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2Product Code
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement2Product Code
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement2Product Code
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery2Product Code
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2Product Code
- OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects2Product Code
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects2Product Code
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2Product Code
- OXLMesh, Surgical, Absorbable, Organ Support2Product Code
- OXMMesh, Surgical, Absorbable, Fistula2Product Code
- OXNMesh, Surgical, Collagen, Fistula2Product Code
- PIJCollagen Surgical Mesh Containing Drugs2Product Code
- PQNCarbon Dioxide Gas Controlled Tissue Expander2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
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- UnknownReview Panel
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Page Type
- Product Code
- Definition
- Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General and Plastic Surgery
- Submission Type
- PMA
- Device Classification
- Class 3
- Regulation Number
- 878.3540
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.3540 Silicone gel-filled breast prosthesis
§ 878.3540 Silicone gel-filled breast prosthesis.
(a) Identification—(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast.
(2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.
(3) Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.
(b) Classification. Class III.
(c) Date premarket approval application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or before July 9, 1991 for any silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 9, 1991 been found to be substantially equivalent to a silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed in commercial distribution.
[53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991]