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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 NameADVANTIO, INGENIO, VITALIO, AND FORMIO
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberN970003
Supplement NumberS152
Date Received05/22/2013
Decision Date07/25/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 2869 zoomview programmer software application v1. 09 and ingenio firmware version d_v1. 02 with patch v1. 01 for the devices.
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