SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P
FDA premarket approval P990004/S007 · decided 2005-01-07
Approval details
- PMA number
- P990004
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2004-11-16
- Decision date
- 2005-01-07
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT ISOTRON PLC, SWINDON, UNITED KINGDOM.
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