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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantPfizer, Inc.
235 E. 42nd St.
Ny, NY 10017
PMA NumberN18286
Supplement NumberS021
Date Received05/09/2011
Decision Date07/09/2011
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT GELFOAM PLUS COMPRESSED. THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE. THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY. THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROMBIN TO A PHYSICIAN DURING SURGERY.
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