MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
FDA premarket approval P890055/S055 · decided 2014-05-22
Approval details
- PMA number
- P890055
- Supplement
- S055
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2014-04-28
- Decision date
- 2014-05-22
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.
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