|
Device | ADVANTIO, INGENIO PG FAMILIES |
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 | S160 |
Date Received | 03/18/2014 |
Decision Date | 05/15/2014 |
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 CHANGES IN TRACE COBALT CONTROL LIMIT IN RAW MNO2 ANDTRACE CALCIUM CONTROL LIMIT IN RAW LITHIUM FOIL FOR THE PULSE GENERATOR BATTERIES. |