|
Device | ADVANTIO, INGENIO AND VITALIO PACEMAKERS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | N970003 |
Supplement Number | S171 |
Date Received | 02/23/2015 |
Decision Date | 03/23/2015 |
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 MANUFACTURE THE BATTERY FEEDTHRU SUBASSEMBLY USED IN THE DEVICES AT THE ST. PAUL FACILITY.. |