PMA P010012S602

Device: ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S602
Product code: NIK
Decision date: 2026-02-13
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: qualifying an alternate supplier for outer tray packaging

Current openFDA PMA Record#

Device: ACUITY™ X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S602
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-02-13
Decision code: OK30
Date received: 2026-01-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: qualifying an alternate supplier for outer tray packaging