- Device
- ACUITY Spiral Coronary Venous Pace/Sense Lead, ACUITY X4 Coronary Venous Pace/Sense Lead
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S551
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2022-03-08
- Decision code
- OK30
- Date received
- 2022-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add sterilization chamber equipment to the Dorado, Puerto Rico manufacturing facility.