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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.
 
DevicePulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS255
Date Received03/04/2024
Decision Date08/30/2024
Product Code DXY 
Advisory Committee Cardiovascular
Clinical TrialsNCT05251363
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for expanding the Indications for Use of the Solia S lead to include placement and pacing in the left bundle branch area as an alternative to standard right ventricular pacing.
Post-Approval StudyShow Report Schedule and Study Progress
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