ABSORBABLE SURGICAL SUTURE, USP
FDA premarket approval N10389/S019 · decided 1983-06-03
Approval details
- PMA number
- N10389
- Supplement
- S019
- Trade name
- ABSORBABLE SURGICAL SUTURE, USP
- Generic name
- Suture, absorbable, natural
- Applicant
- ETHICON, Inc.
- Date received
- 1983-04-27
- Decision date
- 1983-06-03
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- GAL
- 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.