SURGIFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval P990004/S018 · decided 2010-07-28
Approval details
- PMA number
- P990004
- Supplement
- S018
- Supplement type
- Real-Time Process
- 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
- 2010-06-23
- Decision date
- 2010-07-28
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL TO CHANGE THE INSTRUCTIONS FOR USE TO ADD SPECIFIC DIRECTIONS FOR USE OF THE DEVICE IN ENDOSCOPIC AND/OR LAPAROSCOPIC PROCEDURES.
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