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 | ANGIO-SEAL VASCULAR CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S067 |
Date Received | 07/05/2011 |
Decision Date | 04/15/2013 |
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 A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL, INC., IN MINNETONKA, MINNESOTA. |
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