GELFOAM ABSORBABLE GELATIN POWDER
FDA premarket approval N18286/S011 · decided 1999-04-26
Approval details
- PMA number
- N18286
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GELFOAM ABSORBABLE GELATIN POWDER
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 1999-04-05
- Decision date
- 1999-04-26
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder.
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