PMA P970003S180
- Device
- DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S180
- Product code
- MUZ
- Decision date
- 2015-07-08
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- USE OF AN ALTERNATE ELECTRICAL TEST SYSTEM (ETS) KNOWN AS THE UNIVERSAL TEST SYSTEM (UTS) FOR THE MODEL 106 GENERATOR.
Current openFDA PMA Record#
- Device
- DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S180
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-07-08
- Decision code
- OK30
- Date received
- 2015-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE ELECTRICAL TEST SYSTEM (ETS) KNOWN AS THE UNIVERSAL TEST SYSTEM (UTS) FOR THE MODEL 106 GENERATOR.