Identity
- Trade Name
- MOSAIC ULTRA® FDA UDI
- Generic Name
- Aortic open-surgery heart valve bioprosthesis FDA UDI
- Device Name
- VLV 305U221 MOSAIC AOR ULT CII NNA US TE FDA UDIVALVE 305U221 MOS AOR ULT CINCHII US FDA UDIVLV 305U221 MOSAIC AOR ULT CII US TEMP I FDA UDIVLV 305U221 MOSAIC AORULT CII US PEEK FDA UDI
- Model / Reference
- 305U221 FDA UDI
- Description
- VLV 305U221 MOSAIC AOR ULT CII NNA US TE FDA UDIVALVE 305U221 MOS AOR ULT CINCHII US FDA UDIVLV 305U221 MOSAIC AOR ULT CII US TEMP I FDA UDIVLV 305U221 MOSAIC AORULT CII US PEEK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169001831 FDA UDI00613994479259 FDA UDI00643169001848 FDA UDI00643169594944 FDA UDI
- PMA Number
- P990064 FDA UDI
- FDA Product Code
- LWR FDA UDI
- GMDN Term
- Aortic open-surgery heart valve bioprosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDINot 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
Category: Aortic open-surgery heart valve bioprosthesis
Mosaic Ultra® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic open-surgery heart valve bioprosthesis.
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- Trifecta™ — ST. JUDE MEDICAL, INC. · Class III
- CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
- CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
- Biocor™ — ST. JUDE MEDICAL, INC. · Class III
- INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
Cleared under the same submission
P990064 also covers:
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC ULTRA® — MEDTRONIC, INC.
- MOSAIC® — MEDTRONIC, INC.
- MOSAIC® — MEDTRONIC, INC.
- MOSAIC® — 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 (4)
- FDA UDI b9cf7ef1-e091-465f-b80b-ef3eebda7fd2 37 fields · synced Jun 8, 2026
- FDA UDI de34d59d-1992-4c02-8e86-fd5e928ef6e3 38 fields · synced May 24, 2026
- FDA UDI 06886744-1261-433c-8e05-f9609890099f 37 fields · synced May 24, 2026
- FDA UDI 6a3499bd-fc83-4ad7-85e7-0b7f19017aa8 37 fields · synced May 25, 2026