PMA P910073S190

Device: ACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit
Applicant: Boston Scientific
PMA number: P910073
Supplement: S190
Product code: LWS
Decision date: 2026-05-15
Classification: Cardiovascular
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: ACUITY™ X4 Connector Tool (Model 4625); RELIANCE™ 4-FRONT Suture Sleeve (aka Lead Stabilizer) (Model 6403); Lead Cap Kit
Applicant: Boston Scientific
PMA number: P910073
Supplement: S190
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.