PROLENE POLYPROPYLENE NONAB.SURG. SUTURE
FDA premarket approval N16374/S022 · decided 1981-06-11
Approval details
- PMA number
- N16374
- Supplement
- S022
- Trade name
- PROLENE POLYPROPYLENE NONAB.SURG. SUTURE
- Generic name
- Suture, nonabsorbable, synthetic, polyethylene
- Applicant
- ETHICON, Inc.
- Date received
- 1981-02-11
- Decision date
- 1981-06-11
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- GAT
- 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.