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PMA P150012S183

Device
Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402
Applicant
Boston Scientific
PMA number
P150012
Supplement
S183
Product code
LWP
Decision date
2026-05-15
Classification
Cardiovascular
Generic name
Implantable pulse generator, pacemaker (non-CRT)
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.

Current openFDA PMA Record#

Device
Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY™ Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402
Applicant
Boston Scientific
PMA number
P150012
Supplement
S183
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2026-05-15
Decision code
OK30
Date received
2026-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.