PROMUS Element™ Plus H7493911424350

GUDID 08714729808039

Everolimus-Eluting Platinum Chromium Coronary Stent System

BOSTON SCIENTIFIC CORPORATION

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

• Primary Device ID: 08714729808039
• NIH Device Record Key: d620d9f8-59a7-472d-aa5c-04cc45880d45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROMUS Element™ Plus
• Version Model Number: H7493911424350
• Catalog Number: H7493911424350
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729808039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110010

FDA Product Code

• NIQ: Coronary drug-eluting stent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2014-09-24

On-Brand Devices [PROMUS Element™ Plus]

• 08714729807742: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807735: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807728: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807704: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807698: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807681: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807650: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807636: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807629: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807605: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807599: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807568: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807551: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807544: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807537: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807520: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807513: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807506: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807476: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807469: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807452: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807445: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807438: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807421: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807414: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807407: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807391: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807384: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807360: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807353: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807346: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807339: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807322: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807315: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807308: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729807285: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823773: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823766: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823759: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823742: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823735: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823728: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823711: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823704: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823698: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729823681: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729808114: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729808107: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729808091: Everolimus-Eluting Platinum Chromium Coronary Stent System
• 08714729808084: Everolimus-Eluting Platinum Chromium Coronary Stent System