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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 NameIMPLANTABLE PULSE GENERATOR PACEMAKER
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP940031
Supplement NumberS068
Date Received07/15/2010
Decision Date08/13/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
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