|
Device | ADAPTA/VERSA/SENSIA AND RELIA 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 | S244 |
Date Received | 09/27/2011 |
Decision Date | 11/01/2011 |
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 |
Approval Order Statement APPROVAL FOR UPDATES TO MEDTRONICS ADAPTA/ VERSA/SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (IPG) APPLICATION SOFTWARE TO CORRECT THE BATTERY MEASUREMENT LOCK-UP CONDITION. |