SURGIFOAM Absorbable Gelatin Sponge
FDA premarket approval P990004/S035 · decided 2019-07-17
Approval details
- PMA number
- P990004
- Supplement
- S035
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM Absorbable Gelatin Sponge
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2019-02-04
- Decision date
- 2019-07-17
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for adding an additional production autoclave for terminal sterilization.
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