MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S013 · decided 2002-10-18
Approval details
- PMA number
- P890055
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2001-06-06
- Decision date
- 2002-10-18
- Days to decision
- 499 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.