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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.
 
DeviceEdora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS277
Date Received09/05/2025
Decision Date10/01/2025
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
introducing a temporary, additional incoming visual inspection of outer packaging
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