MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S014 · decided 2002-03-29
Approval details
- PMA number
- P890055
- Supplement
- S014
- Supplement type
- Real-Time Process
- 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
- 2002-03-07
- Decision date
- 2002-03-29
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR AN ALTERNATE QUICK START TECHNIQUE TO THE PUMP IMPLANT PROCEDURE.
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