PMA N18286S017
- Device
- GELFOAM PLUS HEMOSTATIC KIT
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S017
- Product code
- LMF
- Decision date
- 2007-12-13
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order 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.
Current openFDA PMA Record#
- Device
- GELFOAM PLUS HEMOSTATIC KIT
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S017
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2007-12-13
- Decision code
- APPR
- Date received
- 2007-05-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.