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 FAMILY CRT-DS |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant |
St. Jude Medical |
15900 valley view ct. |
sylmar, CA 91342-3577 |
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PMA Number | P030054 |
Supplement Number | S122 |
Date Received | 04/02/2009 |
Decision Date | 05/07/2009 |
Product Code |
NIK
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Advisory Committee |
Cardiovascular |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
APPROVAL FOR:1) REPLACING THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITHPLUG/RECEPTACLE CONNECTORS, EPOXY, DIRECT SOLDER OR LASER WELDING.2) USING AN ORGANIC SUBSTRATE FOR THE HYBRID MODULE.3) RECONFIGURING DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS (E.G. HV CONVERTER BOARDASSEMBLY, SENSOR SUPPORT ASSEMBLY) TO INTEGRATE THEM INTO THE HYBRID. |
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