HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE
FDA premarket approval P930030 · decided 1995-08-15
Approval details
- PMA number
- P930030
- Trade name
- HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Coletica S.A.
- Date received
- 1993-08-30
- Decision date
- 1995-08-15
- Days to decision
- 715 days
- Decision code
- APWD
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Lyon
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.