PMA P010012S489
- Device
- Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Origen CRT-D, Origen X4 CRT-D, Autogen CRT-D, Autogen X4
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S489
- Product code
- NIK
- Decision date
- 2018-09-04
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Addition of an alternate supplier for the molybdenum feedthru pin.
Current openFDA PMA Record#
- Device
- Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Origen CRT-D, Origen X4 CRT-D, Autogen CRT-D, Autogen X4
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S489
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-09-04
- Decision code
- OK30
- Date received
- 2018-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for the molybdenum feedthru pin.