• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
Trade NameDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantCARDIOVASCULAR SYSTEMS, INC.
PMA NumberP130005
Date Received03/20/2013
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 No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
-
-