DEVICE: SYNERGY™ (08714729973454)
Device Identifier (DI) Information
SYNERGY™
H7493926024500
In Commercial Distribution
H7493926024500
BOSTON SCIENTIFIC CORPORATION
H7493926024500
In Commercial Distribution
H7493926024500
BOSTON SCIENTIFIC CORPORATION
Everolimus-Eluting Platinum Chromium Coronary Stent System
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? |
---|---|---|---|---|
58771 | Drug-eluting coronary artery stent, bioabsorbable-polymer-coated |
A non-bioabsorbable metal tubular mesh structure covered with a bioabsorbable polymer that contains a drug, 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 is slowly released as the polymer degrades and is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Some types may be dedicated to implantation across a coronary artery bifurcation. Disposable devices associated with implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NIQ | Coronary drug-eluting stent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P150003 | 039 |
P150003 | 043 |
P150003 | 090 |
P150003 | 096 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Stent Diameter: 5.00 Millimeter |
Stent Length: 24 Millimeter |
Device Record Status
5ca5ebf3-a6af-497f-ae0b-c037bc04bbf7
June 21, 2024
5
November 14, 2018
June 21, 2024
5
November 14, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined