DEVICE: ALTRUA™ 2 SR (00802526559327)

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Device Record History
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Device Identifier (DI) Information
ALTRUA™ 2 SR
S701
In Commercial Distribution
S701
BOSTON SCIENTIFIC CORPORATION
00802526559327
GS1

1
106295384 *Terms of Use
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?
47267 Single-chamber implantable pacemaker, rate-responsive
A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.
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 [?]
N970003 167
N970003 170
N970003 182
N970003 186
N970003 208
N970003 209
N970003 216
N970003 229
N970003 231
N970003 234
N970003 241
N970003 255
N970003 265
N970003 275
N970003 278
N970003 280
N970003 292
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b4b8f5cf-58ea-4dff-a864-a1cbfef332ce
June 28, 2024
12
November 11, 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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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