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 SERIES 1500 DEFIBRILLATION LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S014 |
Date Received | 01/31/2002 |
Decision Date | 03/11/2002 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR NEW DEFIBRILLATION LEAD SYSTEMS AND ACCESSORIES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIAT SERIES 1500 (MODELS 1570, 1571, 1580 AND 1581) DEFIBRILLATION LEAD SYSTEM AND ACCESSORIES (S-65-S, S-65-F, S-65-X, TX-070). THESE DEVICES ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS (REFER TO THE APPLICABLE DEFIBRILLATOR MANUAL FOR SYSTEM INDICATIONS.). THEY PROVIDE PACING AND SENSING AND DELIVER CARDIOVERSION/DEFIBRILLATION THERAPY TO THE HEART. |
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