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 | GEM III AT 7276 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S013 |
Date Received | 12/03/2002 |
Decision Date | 02/21/2003 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS. |
Post-Approval Study | Show Report Schedule and Study Progress |
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