PMA P030005S148
- Device
- CRT-P RESYNCHRONIZATION DEVICES, INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S148
- Product code
- NKE
- Decision date
- 2017-02-16
- 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 Model 6290 Patient Communicator software update to version 2.22.00.
Current openFDA PMA Record#
- Device
- CRT-P RESYNCHRONIZATION DEVICES, INVIVE, INTUA, VISIONIST, VALITUDE
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S148
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-02-16
- Decision code
- APPR
- Date received
- 2016-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Model 6290 Patient Communicator software update to version 2.22.00.