PMA P010012S532
- Device
- ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S532
- Product code
- NIK
- Decision date
- 2021-02-24
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Molding fixture update for the Acuity X4 E24 molding process.
Current openFDA PMA Record#
- Device
- ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S532
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-02-24
- Decision code
- OK30
- Date received
- 2021-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Molding fixture update for the Acuity X4 E24 molding process.