PMA P890055S053
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S053
- Product code
- LKK
- Decision date
- 2014-01-22
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR ADDITION OF A 100% INSPECTION TO VERIFY THE USE BY DATE ON THE LABELS OF THE MEDSTREAM IMPLANTABLE INFUSION PUMP SYSTEM.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S053
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2014-01-22
- Decision code
- APPR
- Date received
- 2013-12-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF A 100% INSPECTION TO VERIFY THE USE BY DATE ON THE LABELS OF THE MEDSTREAM IMPLANTABLE INFUSION PUMP SYSTEM.