PMA P030005S122
- Device
- INVIVE,INTUA,VISIONIST,VALITUDE CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S122
- Product code
- NKE
- Decision date
- 2015-07-21
- 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 SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
Current openFDA PMA Record#
- Device
- INVIVE,INTUA,VISIONIST,VALITUDE CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S122
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2015-07-21
- Decision code
- APPR
- Date received
- 2015-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).