- Device
- Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S530
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new X-ray System to the battery manufacturing process.