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 | RIATA DEFIBRILLATION LEAD FAMILY |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S018 |
Date Received | 03/11/2004 |
Decision Date | 04/21/2004 |
Product Code |
LWS |
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 MODIFICATION TO THE RIATA DEFIBRILLATION LEAD FAMILY TO INCLUDE INTEGRATED BIPOLAR LEADS (MODELS 1560, 1561, 1562, 1590, 1591 AND 1592). |
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