Identity
- Trade Name
- Open Pivot™ FDA UDI
- Generic Name
- Mitral bi-leaflet mechanical heart valve prosthesis FDA UDI
- Device Name
- MHV 500DM31 STD MITRAL FDA UDI
- Model / Reference
- 500DM31 FDA UDI
- Description
- MHV 500DM31 STD MITRAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169977778 FDA UDI
- PMA Number
- P990046 FDA UDI
- FDA Product Code
- LWQ FDA UDI
- GMDN Term
- Mitral bi-leaflet mechanical heart valve prosthesis 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
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 31.0 Millimeter FDA UDI
Category: Mitral bi-leaflet mechanical heart valve prosthesis
Open Pivot™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mitral bi-leaflet mechanical heart valve prosthesis.
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- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- CARBOMEDICS OPTIFORM — Corcym Inc. · Class III
Cleared under the same submission
P990046 also covers:
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — MEDTRONIC, INC.
- Open Pivot™ — 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 1d9740bc-7ab6-48e9-9500-c32b9b9aab96 37 fields · synced May 30, 2026