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 | VALITUDE , VALITUDE X4 CRT-PS |
Generic Name | pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) |
Applicant | GUIDANT CORP. 4100 hamline avenue north st. paul, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S132 |
Date Received | 01/08/2016 |
Decision Date | 02/03/2016 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Vertical integration of the manufacturing of the spring connector block housings for the devices. |
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