• 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 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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP950020
Supplement NumberS007
Date Received11/01/2002
Decision Date04/30/2003
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes in the cutting balloon, both the over-the-wire (otw) and monorail (mr) configurations, and for manufacturing changes for the mr configuration. Additionally, approval to add the trade name cutting balloon ultra2 for both configurations and to add warnings to the instructions for use. The device, as modified, will be marketed under the trade name cutting balloon ultra2 and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (<= 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2. 0 mm to 4. 0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.