PMA P080012S016
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S016
- Product code
- LKK
- Decision date
- 2013-07-02
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE CANNULA STRAIN RELIEF AND FILTER SEAL, WHICH ARE BOTH COMPONENTS OF THE IMPLANTABLE PUMP.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE IMPLANTABLE PUMP
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S016
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2013-07-02
- Decision code
- APPR
- Date received
- 2013-04-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE SUB-TIER SUPPLIER AND MATERIAL CHANGE FOR THE MOLDED SILICONE CANNULA STRAIN RELIEF AND FILTER SEAL, WHICH ARE BOTH COMPONENTS OF THE IMPLANTABLE PUMP.