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. |
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Device | GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | PFIZER, INC. 235 EAST 42ND ST. NEW YORK, NY 10017 |
PMA Number | N18286 |
Supplement Number | S022 |
Date Received | 09/06/2011 |
Decision Date | 02/29/2012 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW CONVENIENCE KIT, GELFOAM PLUS ¿ POWDER TO BE COMPRISED OF GELFOAM POWDER, HUMAN THROMBIN, ONE SYRINGE THAT IS PRE-FILLED WITH 0.9% NAC1 SOLUTION, ONE EMPTY SYRINGE, A NEEDLELESS TRANSFER DEVICE AND AN APPLICATOR TIP. |
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