PDS(TM) SUTURE (CLEAR)
FDA premarket approval N18387/S011 · decided 1986-12-03
Approval details
- PMA number
- N18387
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PDS(TM) SUTURE (CLEAR)
- Generic name
- Suture, absorbable, synthetic, polyglycolic acid
- Applicant
- ETHICON, Inc.
- Date received
- 1986-10-28
- Decision date
- 1986-12-03
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- GAM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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