PMA P010012S440
- Device
- ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S440
- Product code
- NIK
- Decision date
- 2016-12-19
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Modifications to the primer dry time, molding tool, and molding cure time used to assemble the distal tip of the ACUITY X4 lead body.
Current openFDA PMA Record#
- Device
- ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S440
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-12-19
- Decision code
- OK30
- Date received
- 2016-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the primer dry time, molding tool, and molding cure time used to assemble the distal tip of the ACUITY X4 lead body.