MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II)
FDA premarket approval P860004/S090 · decided 2008-11-10
Approval details
- PMA number
- P860004
- Supplement
- S090
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II)
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-06-22
- Decision date
- 2008-11-10
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE SOFTWARE CHANGES MADE TO THE SYNCHROMED EL AND SYNCHROMED II APPLICATION SOFTWARE LOCATED ON MODEL 8870 APPLICATION CARD.
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510(k) clearances by this applicant
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