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 | FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S127 |
Date Received | 10/20/2014 |
Decision Date | 12/11/2014 |
Product Code |
NKE |
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 MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES. |
|
|