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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.
 
DeviceStylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP150012
Supplement NumberS183
Date Received04/17/2026
Decision Date05/15/2026
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) division’s Pulse Generators and Leads.
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