PMA P030005S050
- Device
- CONTAK RENEWAL TR/TR2 FAMILY OF PACEMAKERS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S050
- Product code
- NKE
- Decision date
- 2008-03-18
- 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 AN ALTERNATE SUPPLIER FOR THE SURGE SUPPRESSOR FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL TR/TR2 FAMILY OF PACEMAKERS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S050
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2008-03-18
- Decision code
- APPR
- Date received
- 2008-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE SURGE SUPPRESSOR FOR THE DEVICES.