|
Device | VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S033 |
Date Received | 06/08/2010 |
Decision Date | 11/26/2010 |
Product Code |
MRM |
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 ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |