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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 NameVENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS018
Date Received08/30/1996
Decision Date05/06/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for rhythmline(tm) transtelephonic interrogation system which will provide remote interrogation and data retrieval and ecg monitoring of patients with ventak prx ii and prx iii pulse generators.
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