MIC · Implant, Muscle, Pectoralis
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | MIC |
|---|---|
| Device Name | Implant, Muscle, Pectoralis |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021337 | AART PECTORALIS IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 3, 2002 | SESE |
| K002633 | SILMAX PECTORAL IMPLANT | Pillar Surgical, Inc. | Nov 21, 2000 | SESE |
| K983043 | SEARE BIOMEDICAL SILICONE BLOCK | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| K982762 | SEARE BIOMEDICAL PECTORALIS IMPLANT | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| K973729 | POWERFLEX PEC IMPLANT | Hanson Medical, Inc. | Dec 24, 1997 | SESE |
| K961072 | PEC IMPLANT | Rand Scientific Corp. | Apr 19, 1996 | SESE |
| K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT | Spectrum Designs, Inc. | Nov 7, 1994 | SESE |
| K913768 | PEC IMPLANT | Applied Biomaterial Technologies | Feb 3, 1992 | SESE |
Top Applicants
- Seare Biomedical Corp. — 2 clearances
- Spectrum Designs, Inc. — 1 clearance
- Rand Scientific Corp. — 1 clearance
- Pillar Surgical, Inc. — 1 clearance
- Hanson Medical, Inc. — 1 clearance
