Codman 3000 Series Constant Flow Implantable infusion Pump
FDA premarket approval P890055/S069 · decided 2018-07-06
Approval details
- PMA number
- P890055
- Supplement
- S069
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Codman 3000 Series Constant Flow Implantable infusion Pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2017-08-21
- Decision date
- 2018-07-06
- Days to decision
- 319 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for a updated MRI labeling for the Codman 3000 pump.
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