Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Corp.
One Boston Scientific Place
Natick, MA 01760
PMA NumberP980001
Date Received01/28/1998
Decision Date08/11/1998
Withdrawal Date 08/13/2007
Product Code MAF 
Docket Number 99M-1696
Notice Date 06/09/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the NIR ON(TM) Ranger(TM) and NIR ON(TM) Ranger(TM) w/SOX(TM) Premounted Stent Systems. The device is indicated for improving coronary luminal diamter in the following patient subsets: a)patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <25 mm) with a reference vessel diameter of 3.0 to 4.0 mm; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; c) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesion length < 30 mm and reference vessel diamter in the range of 3.0 to 4.0mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S006 S008 S009 S010 S011 S012 S013 
S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S035 S036 S037 S038 S039 
S040 S041 S043 
-
-