Tendyne™ TENDV-SP-35S

GUDID 05415067032492

Mitral Valve

ST. JUDE MEDICAL, INC.

Mitral transcatheter heart valve bioprosthesis
Primary Device ID05415067032492
NIH Device Record Key50061c7a-4c82-4276-9a9b-cda29813a4e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTendyne™
Version Model NumberTENDV-SP-35S
Catalog NumberTENDV-SP-35S
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 116 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067032492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPUProsthesis, mitral valve, percutaneously delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

On-Brand Devices [Tendyne™]

05415067046192Retrieval System
05415067032720Stand Components
05415067032713Pad Positioning System
05415067032706Loading System
05415067032690Delivery System
05415067032683Apical Pad - Large
05415067032676Apical Pad - Small
05415067032669Mitral Valve
05415067032652Mitral Valve
05415067032645Mitral Valve
05415067032638Mitral Valve
05415067032621Mitral Valve
05415067032614Mitral Valve
05415067032607Mitral Valve
05415067032591Mitral Valve
05415067032584Mitral Valve
05415067032577Mitral Valve
05415067032560Mitral Valve
05415067032553Mitral Valve
05415067032546Mitral Valve
05415067032539Mitral Valve
05415067032522Mitral Valve
05415067032515Mitral Valve
05415067032508Mitral Valve
05415067032492Mitral Valve
05415067032485Mitral Valve
05415067032478Mitral Valve
05415067032461Mitral Valve
05415067032454Mitral Valve
05415067032447Mitral Valve
05415067032096Stand
054150670320272 lb Weight

Trademark Results [Tendyne]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TENDYNE
TENDYNE
86609447 not registered Live/Pending
Tendyne Holdings, Inc.
2015-04-24
TENDYNE
TENDYNE
85669495 not registered Dead/Abandoned
Tendyne Holdings, Inc.
2012-07-05

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