PMA P030005S119
- Device
- INGENIO 2 CRT-P DEVICES
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S119
- Product code
- NKE
- Decision date
- 2015-05-19
- 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 DESIGN CHANGES TO THE IS4 OUTER SLEEVE AND VERTICAL INTEGRATION OF IS4 OUTER SLEEVE MANUFACTURING.
Current openFDA PMA Record#
- Device
- INGENIO 2 CRT-P DEVICES
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S119
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2015-05-19
- Decision code
- APPR
- Date received
- 2015-03-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE IS4 OUTER SLEEVE AND VERTICAL INTEGRATION OF IS4 OUTER SLEEVE MANUFACTURING.