SYNCHROMED II INFUSION SYSTEM
FDA premarket approval P860004/S112 · decided 2009-09-18
Approval details
- PMA number
- P860004
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED II INFUSION SYSTEM
- Applicant
- Medtronic, Inc.
- Date received
- 2009-08-21
- Decision date
- 2009-09-18
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- AUTOMATION OF THE TRANSFER OF FINAL FUNCTIONAL TEST DATA TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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