Tendyne™ TENDV-LP-29S
GUDID 05415067032652
Mitral Valve
ST. JUDE MEDICAL, INC.
Mitral transcatheter heart valve bioprosthesis| Primary Device ID | 05415067032652 |
| NIH Device Record Key | 69dffe8b-7940-4941-a298-ba0dff1da3d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tendyne™ |
| Version Model Number | TENDV-LP-29S |
| Catalog Number | TENDV-LP-29S |
| 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 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use the valve if the shipping temperature indicator has turned red or black |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067032652 [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 |
Trademark Results [Tendyne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENDYNE 86609447 not registered Live/Pending |
Tendyne Holdings, Inc. 2015-04-24 |
 TENDYNE 85669495 not registered Dead/Abandoned |
Tendyne Holdings, Inc. 2012-07-05 |
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