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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 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.
 
DeviceVENTRITEX HOUSECALL RECEIVER/TRANSMITTER
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS043
Date Received04/26/1999
Decision Date08/04/1999
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the transtelephonic follow-up system. The device, as modified, will be marketed under the trade name Housecall(TM) 2.0 system and is indicated for use with the Ventritex(R) Tiered-Therapy Defibrillators.
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