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CareLink SmartSync™ Percepta Serena Solara Application
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- CareLink SmartSync™ Percepta Serena Solara Application FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- SW D00U004 SS PERCEPTA SERENA SOLERA FDA UDI
- Model / Reference
- D00U004 FDA UDI
- Description
- SW D00U004 SS PERCEPTA SERENA SOLERA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000002046 FDA UDI
- PMA Number
- P010015 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Implantable cardiac device management application software FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable cardiac device management application software
CareLink SmartSync™ Percepta Serena Solara Application by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P010015 also covers:
- ATTAIN® BIPOLAR OTW — MEDTRONIC, INC.
- Consulta® CRT-P — MEDTRONIC, INC.
- Percepta™ CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Percepta™ CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Percepta™ Quad CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Percepta™ Quad CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Serena™ CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Serena™ CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Serena™ Quad CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Serena™ Quad CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Solara™ CRT-P MRI SureScan™ — MEDTRONIC, INC.
- Solara™ CRT-P MRI SureScan™ — 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 17e7aa59-ea67-4bed-80c4-86ce47eaf82f 35 fields · synced May 31, 2026