PMA P030005S152
- Device
- Invive, Intua, Visionist, Valitude
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S152
- Product code
- NKE
- Decision date
- 2017-09-11
- 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 the Model 3300 LATITUDE Programming System.
Current openFDA PMA Record#
- Device
- Invive, Intua, Visionist, Valitude
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S152
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 3300 LATITUDE Programming System.