DEVICE: VISIONIST™ CRT-P (00802526559457)

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Device Record History
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Device Identifier (DI) Information
VISIONIST™ CRT-P
U226
In Commercial Distribution
U226
BOSTON SCIENTIFIC CORPORATION
00802526559457
GS1

1
106295384 *Terms of Use
Cardiac Resynchronization Therapy Pacemaker
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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?
47263 Cardiac resynchronization therapy implantable pacemaker
A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030005 138
P030005 156
P030005 157
P030005 164
P030005 176
P030005 180
P030005 186
P030005 201
P030005 210
P030005 220
P030005 223
P030005 225
P030005 237
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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
60fcb13d-41a8-45a2-807f-16ee8025816f
June 28, 2024
12
March 09, 2017
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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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