PMA P910073S188

Device: • ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S
Applicant: Boston Scientific
PMA number: P910073
Supplement: S188
Product code: LWS
Decision date: 2026-04-10
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches

Current openFDA PMA Record#

Device: • ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S
Applicant: Boston Scientific
PMA number: P910073
Supplement: S188
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-02-04
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches