PMA P030005S046
- Device
- CONTAK RENEWAL TR CRT-P SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S046
- Product code
- NKE
- Decision date
- 2007-12-20
- 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 UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL TR CRT-P SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S046
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2007-12-20
- Decision code
- APPR
- Date received
- 2007-08-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM.