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 | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S042 |
Date Received | 10/18/2006 |
Decision Date | 11/16/2006 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS. |
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