SEPRAFILM ADHESION BARRIER
FDA premarket approval P950034/S044 · decided 2016-01-07
Approval details
- PMA number
- P950034
- Supplement
- S044
- 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
- 2015-12-10
- Decision date
- 2016-01-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- ADDITIONAL SUPPLIER OF POLY(METHYL METHACRYLATE) (PMMA), PLASKOLITE, TO BE QUALIFIED FOR USE IN THE MANUFACTURE OF THE CASTING SHEETS PRODUCED BY AIN PLASTICS. THE CASTING SHEETS ARE IN TURN USED IN THE MANUFACTURE OF THE DEVICE (SEPRAFILM).
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