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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.
 
DeviceIperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic Implantab
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP050023
Supplement NumberS102
Date Received06/09/2016
Decision Date07/27/2016
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the Siello S and Solia S leads to the ProMRI CRT-D system.
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