CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S065 · decided 2016-09-26
Approval details
- PMA number
- P890055
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CODMAN 3000 CONSTANT-FLOW IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2016-08-29
- Decision date
- 2016-09-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Use a suture material for the Codman 3000 Implantable Infusion Pump from a supplier that has changed ownership from Sherwood Davis & Geck to Medtronic.
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