PMA P030005S134
- Device
- CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S134
- Product code
- NKE
- Decision date
- 2016-07-08
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval for LATITUDE NXT Patient Management System, Release 4.1.1.
Current openFDA PMA Record#
- Device
- CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S134
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2016-07-08
- Decision code
- APPR
- Date received
- 2016-04-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for LATITUDE NXT Patient Management System, Release 4.1.1.