PMA P010012S534
- Device
- ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads
- Applicant
- Boston Scientific Corp
- Product code
- NIK
- Decision date
- 2021-04-28
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Acceptance to duplicate five lead subassembly manufacturing processes.
Current openFDA PMA Record#
- Device
- ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S534
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance to duplicate five lead subassembly manufacturing processes.