PMA P010012S520
- Device
- ACUITY X4
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S520
- Product code
- NIK
- Decision date
- 2020-07-07
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- ACUITY X4
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S520
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-07-07
- Decision code
- APPR
- Date received
- 2020-04-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.