DEVICE: SYNERGY™ (08714729840589)

Device Identifier (DI) Information

SYNERGY™
H7493926116270
In Commercial Distribution
H7493926116270
BOSTON SCIENTIFIC CORPORATION
08714729840589
GS1

1
021717889 *Terms of Use
Everolimus-Eluting Platinum Chromium Coronary Stent System
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
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?
56284 Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NIQ Coronary drug-eluting stent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P150003 000
P150003 002
P150003 003
P150003 006
P150003 011
P150003 032
P150003 036
P150003 058
P150003 063
P150003 090
P150003 096
No CLOSE

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
Device Size Text, specify: 2.75 mm Stent Diameter
Device Size Text, specify: 16 mm Stent Length
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Device Record Status

dea1f226-7d10-47f4-b046-9640d1427032
June 21, 2024
9
January 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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