- Device
- ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S535
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Clarify the terminal pin welding fixture loading process instruction.