|
Device | Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S298 |
Date Received | 03/31/2016 |
Decision Date | 04/22/2016 |
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 Add an alternate material for a manufacturing gauge tool. |