SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP
FDA premarket approval N11397/S027 · decided 1988-12-28
Approval details
- PMA number
- N11397
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP
- Generic name
- Suture, nonabsorbable, silk
- Applicant
- ETHICON, Inc.
- Date received
- 1988-02-17
- Decision date
- 1988-12-28
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- GAP
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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