|
Device | VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S239 |
Date Received | 12/16/2010 |
Decision Date | 01/14/2011 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A LASER CLEAVE CUT REWORK PROCESS FOR THE PULSE GENERATOR CAPACITOR STACK MANUFACTURING PROCESS. |