| 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 | LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM |
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| Generic Name | Implantable cardioverter defibrillator (non-CRT) |
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| Applicant | MicroPort CRM USA, Inc.
5640 Airline Road
Arlington, TN 38002 |
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| PMA Number | P970024 |
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| Supplement Number | S001 |
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| Date Received | 11/10/1998 |
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| Decision Date | 03/05/1999 |
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Withdrawal Date
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10/03/2022 |
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| Product Code |
LWS |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the Lyra(TM) ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009, Angepass(TM) RV Defibrillation Lead System (Model 4040, 4041, and 4042), and AngePass(TM) SVC Defibrillation Lead System (Models 4080, 4081, and 4082). The devices as modified will be marketed under the trade names Lyra(TM) and AngePass(TM), and are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; and 2)Recurrent, poorly tolerated, sustained ventricular tachyarrhythmia. |
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