SynchroMed II (Model 8637) pump
FDA premarket approval P860004/S276 · decided 2017-05-26
Approval details
- PMA number
- P860004
- Supplement
- S276
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SynchroMed II (Model 8637) pump
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2017-04-27
- Decision date
- 2017-05-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Removal of inspections of the Pumphead Gear at the Medtronic facility before the subcomponent is further manufactured into the Pumphead Assembly.
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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 |
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