ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA premarket approval P930030/S001 · decided 1995-11-30
Approval details
- PMA number
- P930030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Coletica S.A.
- Date received
- 1995-11-02
- Decision date
- 1995-11-30
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Lyon
- Statement
- APPROVAL FOR A CHANGE IN TRADE NAME THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
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