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 | PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S090 |
Date Received | 05/18/2015 |
Decision Date | 10/09/2015 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW MANUFACTURING SITES LOCATED AT ABBOTT VASCULAR, INC., IN TIPPERARY IRELAND, AND SYNERGY HEALTH IRELAND LTD., IN OFFALY IRELAND. |
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