PMA P010012S604

Device: Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S604
Product code: NIK
Decision date: 2026-04-10
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches

Current openFDA PMA Record#

Device: Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S604
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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