lntera 3000 Hepatic Artery Infusion Pump
FDA premarket approval P890055/S079 · decided 2022-01-27
Approval details
- PMA number
- P890055
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- lntera 3000 Hepatic Artery Infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2022-01-14
- Decision date
- 2022-01-27
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Change in the supplier of Can component of the Intera 3000 pump.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.