PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S
FDA premarket approval N16374/S028 · decided 1985-06-10
Approval details
- PMA number
- N16374
- Supplement
- S028
- Trade name
- PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S
- Generic name
- Suture, nonabsorbable, synthetic, polyethylene
- Applicant
- ETHICON, Inc.
- Date received
- 1984-03-05
- Decision date
- 1985-06-10
- Days to decision
- 462 days
- Decision code
- APPR
- Product code
- GAT
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
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