PMA P080012S024
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S024
- Product code
- LKK
- Decision date
- 2015-02-12
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR IMPLEMENTING A MIXED LOAD STERILIZATION CONFIGURATION FOR THE PROMETRA PUMPS ACCESSORY KITS, WHICH ARE ETHYLENE OXIDE STERILIZED.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S024
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2015-02-12
- Decision code
- APPR
- Date received
- 2014-11-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPLEMENTING A MIXED LOAD STERILIZATION CONFIGURATION FOR THE PROMETRA PUMPS ACCESSORY KITS, WHICH ARE ETHYLENE OXIDE STERILIZED.