GELFOAM PLUS HEMOSTASIS KIT
FDA premarket approval N18286/S018 · decided 2009-06-10
Approval details
- PMA number
- N18286
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GELFOAM PLUS HEMOSTASIS KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2009-02-26
- Decision date
- 2009-06-10
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL OF CHANGES TO THE MANUFACTURING OF THE HUMAN THROMBIN COMPONENT OF THE GELFOAM PLUS HEMOSTASIS KIT THROUGH THE ADDITION OF A SOLVENT/ DETERGENT STEP (HUMAN THROMBIN VH S/D). THE THROMBIN IS TO BE MANUFACTURED AND SUPPLIED BY BAXTER HEALTHCARE CORPORATION.
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| MEC HIP BOLT (K850413) | Pfizer, Inc. | 1985-07-15 |
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