Intera 3000 Hepatic Arterial Infusion Pump
FDA premarket approval P890055/S090 · decided 2025-05-07
Approval details
- PMA number
- P890055
- Supplement
- S090
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intera 3000 Hepatic Arterial Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2025-04-11
- Decision date
- 2025-05-07
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- The addition of an inspection process for the Capillary Assembly, the addition of two tools that guide the insertion depth of the Capillary Assembly, and the change of material for the pointer tool used in the manufacturing process.
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