SEPRAFILM ADHESION BARRIER
FDA premarket approval P950034/S042 · decided 2014-08-12
Approval details
- PMA number
- P950034
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2014-07-14
- Decision date
- 2014-08-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- ADDITIONAL SITE FOR QUARTERLY IRRADIATION DOSE VERIFICATION FOR THE SEPRAFILM ADHESION BARRIER.
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