PMA P890055S034
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S034
- Product code
- LKK
- Decision date
- 2011-06-21
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL TO ADD A WARNING STATEMENT TO THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Applicant
- Intera Oncology
- PMA number
- P890055
- Supplement
- S034
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2011-06-21
- Decision code
- APPR
- Date received
- 2011-05-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD A WARNING STATEMENT TO THE INSTRUCTIONS FOR USE.