|
Device | RELAY/DASH/STRIDE/DART PACING SYSTEMS |
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 | S015 |
Date Received | 03/08/1996 |
Decision Date | 08/19/1996 |
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 USE OF AN ALTERNATE CONDUCTIVE EPOXY AND A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS |