Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | PARADYM ICDS AND CRT-D DEVICES |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S060 |
Date Received | 08/12/2010 |
Decision Date | 09/08/2010 |
Product Code |
MRM |
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 THE DESIGN CHANGES FOR LOW VOLTAGE ELECTRONIC HYBRID MODULE AND INTERCONNECTION FLEX CIRCUIT FOR PARADYM VR/DR AND CRT-D, MODELS 8250, 8550, AND 8750. |
|
|