CATGUT SUTURE (PLAIN!CHROMIC) ABSORBABLE
FDA premarket approval N8536/S010 · decided 1981-07-07
Approval details
- PMA number
- N8536
- Supplement
- S010
- Trade name
- CATGUT SUTURE (PLAIN!CHROMIC) ABSORBABLE
- Generic name
- Suture, absorbable, natural
- Applicant
- ETHICON, Inc.
- Date received
- 1980-12-04
- Decision date
- 1981-07-07
- Days to decision
- 215 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.