PMA P010012S341
- Device
- DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S341
- Product code
- NIK
- Decision date
- 2014-04-11
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.
Current openFDA PMA Record#
- Device
- DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S341
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-04-11
- Decision code
- APPR
- Date received
- 2013-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.