Intera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S085 · decided 2024-09-03
Approval details
- PMA number
- P890055
- Supplement
- S085
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intera 3000 Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2024-03-07
- Decision date
- 2024-09-03
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- moving the sterilization site for the Tapered Catheter and Intera Oncology office headquarters
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