PMA P010012S611

Device: ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S611
Product code: NIK
Decision date: 2026-06-09
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 Brooklyn Park

Current openFDA PMA Record#

Device: ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S611
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-06-09
Decision code: OK30
Date received: 2026-05-11
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 Brooklyn Park