|
Device | ADAPTA/VERSA/SENSIA/RELIA IPG IMPLANTABLE PULSE GENERATOR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S147 |
Date Received | 11/17/2009 |
Decision Date | 03/22/2011 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR NEW APPLICATION SOFTWARE VERSION SW003 (VERSION 7.1); RELIA APPLICATION SOFTWARE VERSION SW010 (VERSION 7.1); AND CARELINK DDMA VERSION K3 DDMA1 2V4. |