GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT
FDA premarket approval N18286/S019 · decided 2010-04-08
Approval details
- PMA number
- N18286
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2010-03-17
- Decision date
- 2010-04-08
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.
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| MEC HIP BOLT (K850413) | Pfizer, Inc. | 1985-07-15 |
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