• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSynergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
Generic Namecoronary drug-eluting stent
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311
PMA NumberP150003
Supplement NumberS058
Date Received12/05/2019
Decision Date08/10/2020
Product Code NIQ 
Docket Number 20M-1760
Notice Date 08/14/2020
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems.The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >=2.25 mm to <= 5.00 mm in diameter in lesions <= 34 mm in length.The SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >= 2.25 mm to <= 5.00 mm in diameter in lesions <= 44 mm in length and for high risk bleeding patients with coronary arteries >= 2.25 mm to <= 5.00 mm in diameter in lesions <= 34 mm in length.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
-
-