SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
FDA premarket approval P950034/S003 · decided 1996-12-16
Approval details
- PMA number
- P950034
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 1996-11-22
- Decision date
- 1996-12-16
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- APPROVAL TO EXTEND THE APPROVED 12-MONTH EXPIRATORY PERIOD TO 18 MONTHS.
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