• 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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter, coronary, atherectomy
Applicant
CARDIOVASCULAR SYSTEMS, INC.
651 campus dr
minneapolis, MN 55211
PMA NumberP130005
Date Received03/15/2013
Decision Date10/21/2013
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number 13M-1363
Notice Date 10/30/2013
Advisory Committee Cardiovascular
Clinical Trials NCT01092416
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for the diamondback 360 coronary orbital atherectomy system (oas). The device is indicated to facilitate stent delivery in patients with coronary artery disease (cad) who are acceptable candidates for percutaneous transluminal coronary angioplasty (ptca) or stenting due to de novo, severely calcified coronary artery lesions.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 
-
-