PMA P030005S154
- Device
- Valitude, Visionist
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S154
- Product code
- NKE
- Decision date
- 2017-05-01
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Modification to the software for the Automated Optical Inspection System used during header manufacturing.
Current openFDA PMA Record#
- Device
- Valitude, Visionist
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S154
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-05-01
- Decision code
- OK30
- Date received
- 2017-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the software for the Automated Optical Inspection System used during header manufacturing.