PMA P030005S184
- Device
- INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization Devices
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S184
- Product code
- NKE
- Decision date
- 2019-07-08
- 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 to modify the Model 3300 LATITUDE Programming System software components.
Current openFDA PMA Record#
- Device
- INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization Devices
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S184
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-07-08
- Decision code
- APPR
- Date received
- 2019-04-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the Model 3300 LATITUDE Programming System software components.