|
Device | LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S075 |
Date Received | 01/10/2014 |
Decision Date | 03/11/2014 |
Product Codes |
LWS NIK |
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 A MODIFICATION TO COUPLING CAPACITORS IN THE ELECTRONIC MODULES USED IN THE DEVICES. |