PMA P930035

Device: Hex Wrench (#2) (Model 6501)
Applicant: Boston Scientific
PMA number: P930035
Supplement: S033
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: Hex Wrench (#2) (Model 6501)
Applicant: Boston Scientific
PMA number: P930035
Supplement: S037
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.