PMA P080012S023
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S023
- Product code
- LKK
- Decision date
- 2015-07-29
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR THE PATIENT THERAPY CONTROLLER AND CONFIGURATION DEVICE FOR USE WITH THE PROMETRA PROGRAMMABLE INFUSION SYSTEM.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S023
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-07-29
- Decision code
- APPR
- Date received
- 2014-09-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PATIENT THERAPY CONTROLLER AND CONFIGURATION DEVICE FOR USE WITH THE PROMETRA PROGRAMMABLE INFUSION SYSTEM.