GELFOAM PLUS HEMOSTATS KITS
FDA premarket approval N18286/S027 · decided 2014-11-04
Approval details
- PMA number
- N18286
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GELFOAM PLUS HEMOSTATS KITS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2014-09-29
- Decision date
- 2014-11-04
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- PROPOSED ADDITION OF AN ALTERNATE PRODUCTION AREA FOR GELFOAM BULK SOLUTION MANUFACTURING.
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