PMA P010012S410
- Device
- Dynagen™ Models G150, G151, G154, G156, G158; Inogen™ Models G140, G141, G146, G148; Origen™ Models G050, G051, G056, G0
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S410
- Product code
- NIK
- Decision date
- 2016-03-09
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Vertical integration of the high voltage capacitor can.
Current openFDA PMA Record#
- Device
- Dynagen™ Models G150, G151, G154, G156, G158; Inogen™ Models G140, G141, G146, G148; Origen™ Models G050, G051, G056, G0
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S410
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-03-09
- Decision code
- OK30
- Date received
- 2016-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Vertical integration of the high voltage capacitor can.