DEVICE: ORIGEN™ X4 CRT-D (00802526534515)
Device Identifier (DI) Information
ORIGEN™ X4 CRT-D
G058
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
G058
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
Cardiac Resynchronization Therapy Defibrillator
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47270 | Cardiac resynchronization therapy implantable defibrillator |
An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P010012 | 451 |
P010012 | 453 |
P010012 | 458 |
P010012 | 504 |
P010012 | 506 |
P010012 | 528 |
P010012 | 560 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
636db328-a491-4414-ab98-b13e60626670
March 31, 2023
8
November 03, 2017
March 31, 2023
8
November 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined