Identity
- Trade Name
- SYNCHROMED™ III FDA UDI
- Generic Name
- Implantable intrathecal infusion pump, programmable FDA UDI
- Device Name
- PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN FDA UDI
- Model / Reference
- 8667-40 FDA UDI
- Description
- PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000597030 FDA UDI
- PMA Number
- P860004 FDA UDI
- FDA Product Code
- LKK FDA UDI
- GMDN Term
- Implantable intrathecal infusion pump, programmable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Implantable intrathecal infusion pump, programmable
Synchromed™ Iii by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable intrathecal infusion pump, programmable.
- Prometra II Pump — Flowonix Medical, Inc. · Class III
- Prometra Programmable Pump — Flowonix Medical, Inc. · Class III
- Prometra Programmable Pump — Flowonix Medical, Inc. · Class III
- SYNCHROMED®II — MEDTRONIC, INC. · Class III
- SYNCHROMED® II — MEDTRONIC, INC. · Class III
- SYNCHROMED ® II — MEDTRONIC, INC. · Class III
- SYNCHROMED® II — MEDTRONIC, INC. · Class III
- SynchroMed® II — MEDTRONIC, INC. · Class III
Cleared under the same submission
P860004 also covers:
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- ASCENDA® — MEDTRONIC, INC.
- Ascenda — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
- Ascenda® — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI a1b080c4-e643-446c-a368-d5403e7e093a 37 fields · synced May 30, 2026