SynchroMed II Motor Gear Train Shafts
FDA premarket approval P860004/S261 · decided 2017-04-03
Approval details
- PMA number
- P860004
- Supplement
- S261
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SynchroMed II Motor Gear Train Shafts
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-10-28
- Decision date
- 2017-04-03
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a design and associated manufacturing process changes for the Motor Gear Train Shafts of the SynchroMed II implantable infusion pump. The design change involves applying a thin layer (~1.5?m) of DLC coating, to the three jewel interfacing shafts of the SynchroMed II motor to reduce the sensitivity of the interface to loss of lubrication.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |