Tendyne™ TENDV-SP-35S

GUDID 05415067032492

Mitral Valve

ST. JUDE MEDICAL, INC.

Mitral transcatheter heart valve bioprosthesis

• Primary Device ID: 05415067032492
• NIH Device Record Key: 50061c7a-4c82-4276-9a9b-cda29813a4e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tendyne™
• Version Model Number: TENDV-SP-35S
• Catalog Number: TENDV-SP-35S
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• 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: true
• 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
• Handling Environment Temperature: Between 5 Degrees Celsius and 47 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 116 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067032492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240042

FDA Product Code

• NPU: Prosthesis, mitral valve, percutaneously delivered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

On-Brand Devices [Tendyne™]

• 05415067046192: Retrieval System
• 05415067032720: Stand Components
• 05415067032713: Pad Positioning System
• 05415067032706: Loading System
• 05415067032690: Delivery System
• 05415067032683: Apical Pad - Large
• 05415067032676: Apical Pad - Small
• 05415067032669: Mitral Valve
• 05415067032652: Mitral Valve
• 05415067032645: Mitral Valve
• 05415067032638: Mitral Valve
• 05415067032621: Mitral Valve
• 05415067032614: Mitral Valve
• 05415067032607: Mitral Valve
• 05415067032591: Mitral Valve
• 05415067032584: Mitral Valve
• 05415067032577: Mitral Valve
• 05415067032560: Mitral Valve
• 05415067032553: Mitral Valve
• 05415067032546: Mitral Valve
• 05415067032539: Mitral Valve
• 05415067032522: Mitral Valve
• 05415067032515: Mitral Valve
• 05415067032508: Mitral Valve
• 05415067032492: Mitral Valve
• 05415067032485: Mitral Valve
• 05415067032478: Mitral Valve
• 05415067032461: Mitral Valve
• 05415067032454: Mitral Valve
• 05415067032447: Mitral Valve
• 05415067032096: Stand
• 05415067032027: 2 lb Weight