DEVICE: INCEPTA™ CRT-D (00802526480997)

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Device Record History
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Device Identifier (DI) Information
INCEPTA™ CRT-D
N160
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00802526480997
GS1

1
106295384 *Terms of Use
Cardiac Resynchronization Therapy 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

[?]
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 [?]
P010012 255
P010012 282
P010012 287
P010012 289
P010012 291
P010012 300
P010012 332
P010012 341
P010012 347
P010012 349
P010012 355
P010012 376
P010012 395
P010012 409
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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
e133711c-9d4c-43a2-b911-bf1f6fb7f750
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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