PMA P030005S138
- Device
- VISIONIST, VISIONIST X4, VALITUDE, VALITUDE X4, INVIVE, INTUA
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S138
- Product code
- NKE
- Decision date
- 2016-12-16
- 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 new CRT-P models with additional software features.
Current openFDA PMA Record#
- Device
- VISIONIST, VISIONIST X4, VALITUDE, VALITUDE X4, INVIVE, INTUA
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S138
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2016-12-16
- Decision code
- APPR
- Date received
- 2016-07-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new CRT-P models with additional software features.