PMA P030005
- Device
- INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S227
- Product code
- NKE
- Decision date
- 2026-07-01
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- software changes for the LATITUDE NXT Patient Management System, Release 7.8
Current openFDA PMA Record#
- Device
- INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S253
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- software changes for the LATITUDE NXT Patient Management System, Release 7.8