DEVICE: ENERGEN™ ICD (00802526480744)

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Device Identifier (DI) Information
ENERGEN™ ICD
E143
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00802526480744
GS1

1
106295384 *Terms of Use
Implantable Cardioverter Defibrillator
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Device Characteristics
Labeling does not contain MRI Safety Information
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).
Active true
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FDA Product Code

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Product Code Product Code Name
LWP Implantable pulse generator, pacemaker (non-CRT)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P960040 235
P960040 252
P960040 257
P960040 259
P960040 261
P960040 270
P960040 297
P960040 306
P960040 310
P960040 312
P960040 316
P960040 336
P960040 351
P960040 363
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
242b6354-7a88-4fff-bc7a-214eaea1fd7c
February 05, 2021
4
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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