Intera 3000 Hepatic Artery Infusion Pump accessories
FDA premarket approval P890055/S077 · decided 2021-04-13
Approval details
- PMA number
- P890055
- Supplement
- S077
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intera 3000 Hepatic Artery Infusion Pump accessories
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2021-03-26
- Decision date
- 2021-04-13
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Change in the firms responsible for receiving and inspection activities for the barbed connector and tapered catheter components, cleaning and passivating of the barbed connector component, and packaging, sealing, and labeling of the barbed connector and tapered catheter components for the Intera 3000 Hepatic Artery Infusion Pump.
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