GELFOAM PLUS HEMOSTATIC KIT
FDA premarket approval N18286/S017 · decided 2007-12-13
Approval details
- PMA number
- N18286
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GELFOAM PLUS HEMOSTATIC KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2007-05-24
- Decision date
- 2007-12-13
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL FOR A NEW KIT CONFIGURATION TO INCLUDE HUMAN THROMBIN. THE KIT IS TO BE PREPARED AT THE BAXTER HEALTHCARE CORPORATION PLANT IN HAYWARD, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GELFOAM PLUS HEMOSTASIS KIT AND IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL.
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