PMA P010012S401
- Device
- ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S401
- Decision date
- 2015-10-19
- Approval order statement
- CONVERT ONE SUPER OUTPUT MODULE (SOM) TO ANOTHER SOM BY SUBJECTING IT TO A TEMPERATURE CYCLE SCREENING PROCESS.
Current openFDA PMA Record#
- Device
- ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S401
- Decision date
- 2015-10-19
- Decision code
- OK30
- Date received
- 2015-09-23
- Supplement type
- 30-Day Notice
- Approval order statement
- CONVERT ONE SUPER OUTPUT MODULE (SOM) TO ANOTHER SOM BY SUBJECTING IT TO A TEMPERATURE CYCLE SCREENING PROCESS.