SEPRAFILM ADHESION BARRIER
FDA premarket approval P950034/S028 · decided 2005-12-05
Approval details
- PMA number
- P950034
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Trade name
- SEPRAFILM ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2005-11-18
- Decision date
- 2005-12-05
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- CHANGE IN PERFORMANCE SPECIFICATIONS TO ELIMINATE ETHANOL AND ISOPROPYL ALCOHOL TESTING FROM SEPRAFILM QUALITY CONTROL RELEASE CRITERIA.
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