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Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- Page Type
- Product Code
- Definition
- To repair or replace chordae tendinae.
- Physical State
- Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in repair or replacement of chordae tendinae. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
- Technical Method
- provides tension between the papilary muscles and valve leaflets to prevent valve leaflet prolapse by restoring natural function of the chordae tendinae.
- Target Area
- Mitral and Tricuspid valve apparatus.
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- Cardiovascular
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.5035
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- Yes
- Third Party Review
- Not Third Party Eligible
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CFR § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a) Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
[65 FR 20735, Apr. 18, 2000, as amended at 68 FR 32985, June 3, 2003]