PMA P030005S065
- Device
- CONTAK RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S065
- Product code
- NKE
- Decision date
- 2010-08-13
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S065
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2010-08-13
- Decision code
- OK30
- Date received
- 2010-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REVISION OF INSPECTION PROCEDURES FOR CERAMIC CAPACITORS, CERAMIC NETWORKS, AND CERAMIC CAPACITOR ARRAYS.