PMA P010012S412
- Device
- DYNAGEN ™ CRT-D G150, G151, G154; DYNAGEN ™ X4 CRT-D G156, G158; INOGEN ™ CRT-D G140, G141; INOGEN ™ X4 CRT-D G146, G148
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S412
- Product code
- NIK
- Decision date
- 2016-03-23
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Alternate supplier for the battery cathode tab insulator top/bottom.
Current openFDA PMA Record#
- Device
- DYNAGEN ™ CRT-D G150, G151, G154; DYNAGEN ™ X4 CRT-D G156, G158; INOGEN ™ CRT-D G140, G141; INOGEN ™ X4 CRT-D G146, G148
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S412
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-03-23
- Decision code
- OK30
- Date received
- 2016-02-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the battery cathode tab insulator top/bottom.