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 | VITAGEL SURGICAL HEMOSTAT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | STRYKER CORP. 2825 AIRVIEW BOULEVARD PORTAGE, MI 49002 |
PMA Number | P050044 |
Supplement Number | S001 |
Date Received | 08/08/2006 |
Decision Date | 01/25/2007 |
Withdrawal Date
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07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED CELLPAKER MANUFACTURE BY SPECIAL TEAM MEDICAL SERVICES (YORBA LINDA, CALIFORNIA), TERMINAL STERILIZATION OF THE CELLPAKER BY STERIGENICS US, INC. (SAN DIEGO, CALIFORNIA), AND CHANGE IN CONTRACTOR PERFORMING THE LIMULUS AMEBOCYTE LYSATE ASSAY TO LEXAMED, LTD (TOLEDO, OHIO). |
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