MERSILENE*POLYESTER SUTURE
FDA premarket approval N12815/S019 · decided 1984-03-29
Approval details
- PMA number
- N12815
- Supplement
- S019
- Trade name
- MERSILENE*POLYESTER SUTURE
- Generic name
- Suture, nonabsorbable
- Applicant
- ETHICON, Inc.
- Date received
- 1984-02-01
- Decision date
- 1984-03-29
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- GAO
- 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.