Identity
- Trade Name
- CareLink SmartSync™ PSA Application FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- SW D00U002 CARELINK SMARTSYNC PSA APP FDA UDI
- Model / Reference
- D00U002 FDA UDI
- Description
- SW D00U002 CARELINK SMARTSYNC PSA APP FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3630 FDA UDI870.3720 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™ PSA Application by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163008 also covers:
P890003 also covers:
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- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 32a9e825-7db7-4c24-8b27-215a89de45c6 35 fields · synced Jun 8, 2026