CoreValve™ Evolut™

GUDID 00643169430273

VALVE MCS-P3-29-AOA TAV 29 US COMM MX

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00643169430273
• NIH Device Record Key: bfbbf2f4-d46b-4751-bb9c-2a4df6f3408d
• Commercial Distribution Discontinuation: 2016-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CoreValve™ Evolut™
• Version Model Number: MCS-P3-29-AOA
• Company DUNS: 079527231
• Company Name: MEDTRONIC COREVALVE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169430273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130021

FDA Product Code

• NPT: Aortic valve, prosthesis, percutaneously delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2014-09-23

On-Brand Devices [CoreValve™ Evolut™]

• 00643169448551: VALVE MCS-P3-31-AOA-US TAV 31 US COMM MX
• 00643169448544: VALVE MCS-P3-29-AOA-US TAV 29 US COMM MX
• 00643169448537: VALVE MCS-P3-26-AOA-US TAV 26 US COMM MX
• 00643169448520: VALVE MCS-P4-23-AOA-US TAV 23 US COMM MX
• 00643169448513: VALVE MCS-P3-31-AOA-US TAV 31 US COMM SA
• 00643169448506: VALVE MCS-P3-29-AOA-US TAV 29 US COMM SA
• 00643169448490: VALVE MCS-P3-26-AOA-US TAV 26 US COMM SA
• 00643169448483: VALVE MCS-P4-23-AOA-US TAV 23 US COMM SA
• 00643169430310: VALVE MCS-P4-23-AOA TAV 23 US COMM MX
• 00643169430303: VALVE MCS-P4-23-AOA TAV 23 US COMM SA
• 00643169430297: VALVE MCS-P3-31-AOA TAV 31 US COMM MX
• 00643169430280: VALVE MCS-P3-31-AOA TAV 31 US COMM SA
• 00643169430273: VALVE MCS-P3-29-AOA TAV 29 US COMM MX
• 00643169430266: VALVE MCS-P3-29-AOA TAV 29 US COMM SA
• 00643169430259: VALVE MCS-P3-26-AOA TAV 26 US COMM MX
• 00643169430242: VALVE MCS-P3-26-AOA TAV 26 US COMM SA