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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 NameTEMPO AND META PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator
Regulation Number870.3610
ApplicantPACESETTER, INC.
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: sterilization
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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