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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.
 
DeviceTEMPO AND META PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, CA 91342
PMA NumberP900070
Supplement NumberS023
Date Received09/09/1998
Decision Date10/15/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
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