PMA P830060

Device: Vein Pick (Model 6541)
Applicant: Boston Scientific
PMA number: P830060
Supplement: S088
Product code: LWS
Decision date: 2026-05-15
Generic name: Implantable cardioverter defibrillator (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: Vein Pick (Model 6541)
Applicant: Boston Scientific
PMA number: P830060
Supplement: S093
Product code: LWS
Generic name: Implantable cardioverter defibrillator (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.