- Device
- INVIVE, INTUA, VISIONIST, VALITUDE - CRT-P Resynchronization Devices
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S200
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-10-22
- Decision code
- APPR
- Date received
- 2020-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.