SURGIFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval P990004/S013 · decided 2007-12-27
Approval details
- PMA number
- P990004
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2007-07-05
- Decision date
- 2007-12-27
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR THE REMOVAL OF THE UROLOGIC PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
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