PMA P030005S106
- Device
- CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S106
- Product code
- NKE
- Decision date
- 2014-05-02
- 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 ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S106
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2014-05-02
- Decision code
- APPR
- Date received
- 2014-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.