SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S036 · decided 2019-10-30
Approval details
- PMA number
- P990004
- Supplement
- S036
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2019-10-01
- Decision date
- 2019-10-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for an update to the labeling within the Adverse Events section to strengthen information on adverse reactions related to unapproved uses for catheter embolization.
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