Intera Hepatic Artery Infusion Pump
FDA premarket approval P890055/S074 · decided 2021-06-22
Approval details
- PMA number
- P890055
- Supplement
- S074
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intera Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2020-06-01
- Decision date
- 2021-06-22
- Days to decision
- 386 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for a manufacturing site located at Proven Process Medical Devices, 110 Forbes Road, Mansfield, Massachusetts 02048 which will perform manufacturing of the Intera 3000 Hepatic Artery Infusion Pump (Intera 3000, 30mL high flow rate)
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