PMA P010012S606

Device: ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S606
Product code: NIK
Decision date: 2026-04-22
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: an alternative vapor degreasing solvent used by a supplier, Integer Salem

Current openFDA PMA Record#

Device: ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S606
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-04-22
Decision code: OK30
Date received: 2026-03-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative vapor degreasing solvent used by a supplier, Integer Salem