PDS SUTURE (DYED)
FDA premarket approval N18331/S002 · decided 1982-04-05
Approval details
- PMA number
- N18331
- Supplement
- S002
- Trade name
- PDS SUTURE (DYED)
- Generic name
- Suture, surgical, absorbable, polydioxanone
- Applicant
- ETHICON, Inc.
- Date received
- 1982-01-15
- Decision date
- 1982-04-05
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- NEW
- 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.