PMA P030005S167
- Device
- Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S167
- Product code
- NKE
- Decision date
- 2017-12-11
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.
Current openFDA PMA Record#
- Device
- Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S167
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-12-11
- Decision code
- OK30
- Date received
- 2017-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.