SURGIFOAM ABSORBABLE GELATINE SPONGE, USP
FDA premarket approval P990004/S024 · decided 2014-07-02
Approval details
- PMA number
- P990004
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM ABSORBABLE GELATINE SPONGE, USP
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2014-04-22
- Decision date
- 2014-07-02
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR A MANUFACTURING (PACKAGING) SITE LOCATED AT FERROSAN MEDICAL DEVICES, KOKSOWA, POLAND.
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