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Device | PROGRAMMER SOFTWARE APPLICAION MODEL 2812, VERSION 2.1 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S084 |
Date Received | 08/25/2005 |
Decision Date | 03/23/2007 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR VITALITY AVT PROGRAMMER SOFTWARE (SW) MODEL 2812V2.1 AND THE APPLICABLE FIRMWARE FOR USE ON TE MODEL 3120 PROGRAMMER. |