PMA P010012S610

Device: EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S610
Product code: NIK
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility

Current openFDA PMA Record#

Device: EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S610
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility