|
Device | TELIGEN/INCEPTA/ENERGEN/PUNCTUA/CONFIENT 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 | S250 |
Date Received | 12/29/2011 |
Decision Date | 01/26/2012 |
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 NEW SUPPLIER FOR THE ANTENNA SOCK COMPONENT, AND FOR CHANGES TO THE RECEIVING ACCEPTANCE ACTIVITIES. |