MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S050 · decided 2013-09-23
Approval details
- PMA number
- P890055
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2013-08-30
- Decision date
- 2013-09-23
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- REMOVAL OF A DUPLICATE VISUAL INSPECTION PERFORMED ON TWO ACCESSORY COMPONENTS PACKAGED WITH THE MEDSTREAM INTRATHECAL CATHETER.
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