Intera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S087 · decided 2024-07-12
Approval details
- PMA number
- P890055
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intera 3000 Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2024-06-12
- Decision date
- 2024-07-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Processing change to reduce frequency of bioburden testing from every lot to quarterly
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