PMA P030005S224
- Device
- PG VALITUDE CRT-P, PG VISIONIST CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S224
- Product code
- NKE
- Decision date
- 2022-10-28
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Update the Automated Optical Inspection on the battery feedthrough equipment.
Current openFDA PMA Record#
- Device
- PG VALITUDE CRT-P, PG VISIONIST CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S224
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-10-28
- Decision code
- OK30
- Date received
- 2022-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the Automated Optical Inspection on the battery feedthrough equipment.