DEVICE: ORIGEN™ MINI ICD DR (00802526533747)
Device Identifier (DI) Information
ORIGEN™ MINI ICD DR
D002
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
D002
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
Implantable Cardioverter Defibrillator DR
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? |
---|---|---|---|---|
37265 | Dual-chamber implantable defibrillator |
A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LWS | Implantable cardioverter defibrillator (non-CRT) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P960040 | 394 |
P960040 | 395 |
P960040 | 398 |
P960040 | 438 |
P960040 | 440 |
P960040 | 459 |
P960040 | 484 |
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
2c0788b6-cc7b-4060-87e4-c917a2d02ec7
March 29, 2023
8
November 03, 2017
March 29, 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