Identity
- Trade Name
- ROTAPRO™ FDA UDI
- Generic Name
- Mechanical atherectomy system, coronary, line-powered FDA UDI
- Device Name
- Rotational Atherectomy System FDA UDI
- Model / Reference
- H7493930901R0 FDA UDI
- Description
- Rotational Atherectomy System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729975106 FDA UDI
- PMA Number
- P900056 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- Mechanical atherectomy system, coronary, line-powered 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical atherectomy system, coronary, line-powered
Rotapro™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system, coronary, line-powered.
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coroanry — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
Cleared under the same submission
P900056 also covers:
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
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
- Boston Scientific
Sources (1)
- FDA UDI 3270ce3d-9b29-4203-8fa8-e6ee488babc1 34 fields · synced May 30, 2026