PMA P030005S168
- Device
- VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4, INVIVE, INTUA Cardiac Resynchronization Therapy-Pacemaler (CRT-P)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S168
- Product code
- NKE
- Decision date
- 2017-12-06
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.
Current openFDA PMA Record#
- Device
- VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4, INVIVE, INTUA Cardiac Resynchronization Therapy-Pacemaler (CRT-P)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S168
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-12-06
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.