PMA P970003S185
- Device
- PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S185
- Product code
- MUZ
- Decision date
- 2015-09-30
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE SPOT WELDING SYSTEM USED DURING MANUFACTURE OF THE VNS THERAPY SYSTEM.
Current openFDA PMA Record#
- Device
- PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S185
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2015-09-30
- Decision code
- OK30
- Date received
- 2015-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE SPOT WELDING SYSTEM USED DURING MANUFACTURE OF THE VNS THERAPY SYSTEM.