SUPERSTAT
FDA premarket approval P810040/S006 · decided 1989-01-30
Approval details
- PMA number
- P810040
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPERSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Superstat Corp.
- Date received
- 1988-10-21
- Decision date
- 1989-01-30
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Rancho Dominguez, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.