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. |
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Device | EPIC HF CRT-D SYSTEM |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant |
St. Jude Medical |
15900 valley view ct. |
sylmar, CA 91342-3577 |
|
PMA Number | P030054 |
Supplement Number | S111 |
Date Received | 11/28/2008 |
Decision Date | 12/19/2008 |
Product Code |
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 THE VERSION 3.1 OF THE MODEL EX2000 SOFTWARE FOR THE MERLIN@HOME DEVICES. |
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