PMA P010012S377
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S377
- Product code
- NIK
- Decision date
- 2015-01-06
- 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 ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
Current openFDA PMA Record#
- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S377
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-01-06
- Decision code
- APPR
- Date received
- 2014-11-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.