PMA P970003S157
- Device
- PERENNIADURA MODEL 303 LEAD
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S157
- Product code
- MUZ
- Decision date
- 2013-04-03
- Classification
- Stimulator, Autonomic Nerve, Implanted (depression)
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Approval order statement
- APPROVAL FOR MINOR DESIGN AND MANUFACTURING CHANGES TO THEPERENNIADURA MODEL 303 LEAD.
Current openFDA PMA Record#
- Device
- PERENNIADURA MODEL 303 LEAD
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S157
- Product code
- MUZ
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Decision date
- 2013-04-03
- Decision code
- APPR
- Date received
- 2013-01-24
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MINOR DESIGN AND MANUFACTURING CHANGES TO THEPERENNIADURA MODEL 303 LEAD.