PDS(TM) SUTURE (CLEAR)
FDA premarket approval N18387/S009 · decided 1984-03-27
Approval details
- PMA number
- N18387
- Supplement
- S009
- Trade name
- PDS(TM) SUTURE (CLEAR)
- Generic name
- Suture, absorbable, synthetic, polyglycolic acid
- Applicant
- ETHICON, Inc.
- Date received
- 1983-05-05
- Decision date
- 1984-03-27
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- GAM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.