PMA P030005S183
- Device
- CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S183
- Product code
- NKE
- Decision date
- 2019-06-10
- 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 hardware changes to the Latitude NXT Patient Management System Communicators.
Current openFDA PMA Record#
- Device
- CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S183
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-06-10
- Decision code
- APPR
- Date received
- 2019-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware changes to the Latitude NXT Patient Management System Communicators.