• 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary, angioplasty, percutaneous & operative
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP910031
Supplement NumberS022
Date Received11/16/2004
Decision Date02/16/2006
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the merlin ptca catheter (otw) and nc merlin ptca catheter (otw). The merlin ptca catheter (otw) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The nc merlin ptca catheter (otw) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for the post-delivery expansion of balloon expandable stents.
-
-