FDA.reportPublic FDA data

PMA P010012

Device
ACUITY™ X4 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S566
Product code
NIK
Decision date
2026-05-15
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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 Suture Sleeve (aka Lead Stabilizer) (Model 4603); ACUITY™ X4 Flushing Tool/Wire Guide (Model 4604)
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S608
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.