Medstream Programmable Infusion Pump System
FDA premarket approval P890055/S075 · decided 2021-01-22
Approval details
- PMA number
- P890055
- Supplement
- S075
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medstream Programmable Infusion Pump System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2020-06-11
- Decision date
- 2021-01-22
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for requested replacement of the sealing machine used at Intera Oncology, Inc. (Intera) subcontractor to seal the lid of the syringe barrel, which is a component included in the refill kits approved as accessories for the implanted infusion pumps.
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