PMA P010012S435
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S435
- Product code
- NIK
- Decision date
- 2017-04-17
- 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 LATITUDE NXT Patient Management System Release 5.0.
Current openFDA PMA Record#
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S435
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-04-17
- Decision code
- APPR
- Date received
- 2016-10-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the LATITUDE NXT Patient Management System Release 5.0.