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 | CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S056 |
Date Received | 07/12/2005 |
Decision Date | 08/16/2005 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THIS COMPONENT (ONLY IN CONTAK RENEWAL 3 RF MODELS H210, H215, H250 & H255 AND CONTAK RENEWAL 3 RF HE MODELS H217, H219, H257, & H259); AND 2) CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12. |
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