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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantANGEION CORP.
PMA NumberP970024
Supplement NumberS001
Date Received11/10/1998
Decision Date03/05/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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