- Device
- ACUITY X4 Electrode 2, 3, and (E24)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S512
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-12-06
- Decision code
- OK30
- Date received
- 2019-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an inspection to the ACUITY X4 Electrode 2, 3, and 4 (E24) component manufacturing process.