SURGIFORM ABSORBABLE GELATION SPONGE, USP
FDA premarket approval P990004/S002 · decided 2000-02-08
Approval details
- PMA number
- P990004
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFORM ABSORBABLE GELATION SPONGE, USP
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 1999-11-16
- Decision date
- 2000-02-08
- Days to decision
- 84 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- A change in the "Indications for Use" statement.
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