MedStream Programmable Infusion Pump Control Unit
FDA premarket approval P890055/S070 · decided 2017-10-16
Approval details
- PMA number
- P890055
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MedStream Programmable Infusion Pump Control Unit
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2017-09-22
- Decision date
- 2017-10-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Transfer of the downstream manufacturing processes for the MedStream Control Unit from the Medos Sarl facility to the Medos International facility.
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