|
Device | PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S261 |
Date Received | 05/11/2012 |
Decision Date | 06/19/2012 |
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 MODIFYING THE DESIGN SPECIFICATIONS FOR THE SPOT WELD ANCHOR POST USED IN ICD AND CRT-D PULSE GENERATOR (PG) HEADERS AND THE LEAF SPRING HOUSING BLOCK USED IN THE LV-1 FOR CRT-D PULSE GENERATOR HEADERS. |