Intera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S081 · decided 2022-06-22
Approval details
- PMA number
- P890055
- Supplement
- S081
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Intera 3000 Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2022-05-27
- Decision date
- 2022-06-22
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for changes to Instructions for Use.
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