AccessGUDID - DEVICE: SYNERGY™ (08714729840138)

GUDID

Device Identifier (DI) Information

Brand Name: SYNERGY™
Version or Model: H7493926016400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H7493926016400
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729840138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Everolimus-Eluting Platinum Chromium Coronary Stent System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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	000
P150003	002
P150003	003
P150003	011
P150003	013
P150003	032
P150003	036
P150003	058
P150003	063
P150003	090
P150003	096

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16 mm Stent Length
Device Size Text, specify: 4.00 mm Stent Diameter

Device Record Status

Public Device Record Key: 4815ac6f-1a94-467e-a664-dca965b0af29
Public Version Date: June 21, 2024
Public Version Number: 10
DI Record Publish Date: October 06, 2015