PMA P030005S191
- Device
- Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S191
- Product code
- NKE
- Decision date
- 2019-11-27
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Replace the current Automated Optical Inspection equipment system and to update the inspection process.
Current openFDA PMA Record#
- Device
- Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S191
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-11-27
- Decision code
- OK30
- Date received
- 2019-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the current Automated Optical Inspection equipment system and to update the inspection process.