PMA P010012S426
- Device
- Dynagen™ Models: G150, G151, G154, G156, G158; Inogen™ Models: G140, G141, G146, G148; Origen™
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S426
- Product code
- NIK
- Decision date
- 2016-07-22
- 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 battery weld process.
Current openFDA PMA Record#
- Device
- Dynagen™ Models: G150, G151, G154, G156, G158; Inogen™ Models: G140, G141, G146, G148; Origen™
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S426
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-07-22
- Decision code
- OK30
- Date received
- 2016-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the battery weld process.