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 MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS |
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 | S024 |
Date Received | 03/20/2009 |
Decision Date | 04/17/2009 |
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 CHANGES IN THE STERILIZATION VALIDATION METHOD. |
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