Intera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S082 · decided 2022-10-28
Approval details
- PMA number
- P890055
- Supplement
- S082
- Supplement type
- Special (Immediate Track)
- 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
- 2022-07-29
- Decision date
- 2022-10-28
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for an added inspection of the capillary crimps and tightening of the capillary leakage acceptance criterion.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.