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 | AVITENE MICROFIBBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR 1 G SYRINGE, ENDO AVITENE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard Warwick, RI 02886 |
PMA Number | N17600 |
Supplement Number | S029 |
Date Received | 05/30/2014 |
Decision Date | 06/26/2014 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY. |
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