PMA P030005S227
- Device
- PG VALITUDE CRT-P, PG VISIONIST CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S227
- Product code
- NKE
- Decision date
- 2022-12-20
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Manufacture the accelerometer cover component of pulse generator devices.
Current openFDA PMA Record#
- Device
- PG VALITUDE CRT-P, PG VISIONIST CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S227
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-12-20
- Decision code
- OK30
- Date received
- 2022-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture the accelerometer cover component of pulse generator devices.