- Device
- CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D, ORIGEN CRT-D, INOGEN CRT-D, DYNA
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S542
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility.