PMA P080012S029
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S029
- Product code
- LKK
- Decision date
- 2015-09-01
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR VERSION 1.02.1 OF THE PROMETRA TOUCHSCREEN PROGRAMMER SOFTWARE.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S029
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-09-01
- Decision code
- APPR
- Date received
- 2015-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR VERSION 1.02.1 OF THE PROMETRA TOUCHSCREEN PROGRAMMER SOFTWARE.