PMA P970003S181
- Device
- CYBERONICS VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S181
- Product code
- MUZ
- Decision date
- 2015-07-31
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- USE OF NEW PROCESSES FOR REPROCESSING TABLET COMPUTERS RETURNED FROM THE FIELD AND A PROCESS TO INSTALL PREVIOUSLY APPROVED SOFTWARE UPGRADES ON TABLET COMPUTERS THAT HAVE BEEN DISTRIBUTED TO THE FIELD FOR THE CYBERONICS® VNS THERAPY® SYSTEM TABLET COMPUTERS (MOTION MODEL CL900 OR CYBERONICS MODEL 700, MOTION MODEL CL910 OR CYBERONICS MODEL 720).
Current openFDA PMA Record#
- Device
- CYBERONICS VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S181
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-07-31
- Decision code
- OK30
- Date received
- 2015-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW PROCESSES FOR REPROCESSING TABLET COMPUTERS RETURNED FROM THE FIELD AND A PROCESS TO INSTALL PREVIOUSLY APPROVED SOFTWARE UPGRADES ON TABLET COMPUTERS THAT HAVE BEEN DISTRIBUTED TO THE FIELD FOR THE CYBERONICS® VNS THERAPY® SYSTEM TABLET COMPUTERS (MOTION MODEL CL900 OR CYBERONICS MODEL 700, MOTION MODEL CL910 OR CYBERONICS MODEL 720).