SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637
FDA premarket approval P860004/S137 · decided 2010-09-01
Approval details
- PMA number
- P860004
- Supplement
- S137
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED II IMPLANTABLE INFUSION PUMP MODEL 8637
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-08-09
- Decision date
- 2010-09-01
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGE TO LENGTHEN THE TIME FOR MEASURING THE ALARM OUTPUT OF THE ¿ALARM TEST¿ OF THE DEVICE.
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510(k) clearances by this applicant
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