PMA P970003S165
- Device
- DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S165
- Product code
- MUZ
- Decision date
- 2013-09-05
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- CHANGES TO THE AUTOMATED FUNCTIONAL TEST SOFTWARE.
Current openFDA PMA Record#
- Device
- DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S165
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-09-05
- Decision code
- OK30
- Date received
- 2013-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE AUTOMATED FUNCTIONAL TEST SOFTWARE.