|
Device | MODEL 5019 HIGH VOLTAGE (HV) SPLITTER/ADAPTOR KIT |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S093 |
Date Received | 07/02/2012 |
Decision Date | 02/13/2013 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE MODEL 5019 HIGH VOLTAGE SPLITTER/ ADAPTOR KIT. |
Approval Order | Approval Order |