PMA P010012S415
- Device
- Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S415
- Product code
- NIK
- Decision date
- 2016-05-09
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Automation of transformer component movement at final electrical test and redesign of the associated system fixtures at the supplier.
Current openFDA PMA Record#
- Device
- Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S415
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-05-09
- Decision code
- OK30
- Date received
- 2016-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of transformer component movement at final electrical test and redesign of the associated system fixtures at the supplier.