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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator system & programmer
ApplicantSORIN GROUP- CRM
PMA NumberP980049
Date Received12/18/1998
Decision Date09/15/1999
Product Code
MRM[ Registered Establishments with MRM ]
Docket Number 00M-0915
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced 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; 2) recurrent poorly tolerated, sustained ventricular tachycardia (vt).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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S047 S048 S049 S050 S051 S053 S054 S055 S056 
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S085 S086 S087 S088 S089 S090 S091 S092 S093 
S094 S095 S096 S097 S098 S100 
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