• 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.
 
DeviceASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP160025
Date Received07/22/2016
Decision Date03/23/2017
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 17M-1845
Notice Date 03/29/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01319812
NCT01661231
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Astron Pulsar Stent System and Pulsar-18 Stent System. These devices are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0mm and total lesion lengths up to 190mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 
-
-