|
Device | UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910020 |
Supplement Number | S012 |
Date Received | 09/11/1995 |
Decision Date | 07/31/1996 |
Withdrawal Date
|
07/20/2012 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE UNITY MODEL 292-07 SINGLE PASS (VDDR) PULSE GENERATOR WITH UNIPASS LEADS MODELS 425-02, 425-04 AND 425-06 AND MODEL 531-60 GRAPHICS PROGRAM MODULE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UNITY |