SEPRAFILM
FDA premarket approval P950034/S041 · decided 2012-04-04
Approval details
- PMA number
- P950034
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2012-02-16
- Decision date
- 2012-04-04
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GENZYME NORTHBOROUGH OPERATIONS CENTER (GNOC) IN NORTHBOROUGH, MASSACHUSETTS.
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