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 | VASOSEAL DEVICES |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P920004 |
Supplement Number | S019 |
Date Received | 03/14/2003 |
Decision Date | 04/03/2003 |
Withdrawal Date
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12/06/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO MOVE THE REMAINING CHEMICAL PROCESSING AND TEXTILING OPERATIONS FROM THE MANUFACTURING FACILITY IN VAALS, THE NETHERLANDS TO DATASCOPE'S FACILITY LOCATED IN MAHWAH, NEW JERSEY. |
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