MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
FDA premarket approval P890055/S061 · decided 2015-10-08
Approval details
- PMA number
- P890055
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2015-09-08
- Decision date
- 2015-10-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND
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