MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM
FDA premarket approval P860004/S055 · decided 2002-12-17
Approval details
- PMA number
- P860004
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2002-11-29
- Decision date
- 2002-12-17
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE 8870 SYNCHROMED APPLICATION SOFTWARE, APPROVED AS P860004/S052, FOR USE WITH THE N'VISION PROGRAMMING SYSTEM CONTAINED ON MODEL 8870 APPLICATION CARD. THE SPECIFIC CHANGES ARE: 1) A CHANGE TO THE 8870 SYNCHROMED APPLICATION PROTOCOL DRIVER TO ENSURE SYNCHRONIZATION AND 2) A MICROPROCESSOR-RESET FEATURE TO THE THERAPY STOP FUNCTION TO RESET THE STACK POINTER.
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510(k) clearances by this applicant
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