PMA P010012S605
- Device
- CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S605
- Product code
- NIK
- Decision date
- 2026-04-01
- Classification
- Cardiovascular
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Current openFDA PMA Record#
- Device
- CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S605
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier