SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
FDA premarket approval P950034/S002 · decided 1996-12-17
Approval details
- PMA number
- P950034
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 1996-11-18
- Decision date
- 1996-12-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- NEW MANUFACTURING SITE LOCATED AT GENZYME FINE CHEMICAL, QUALITY CONTROL LABORATORY, ENGLAND
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