Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
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 NameIVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
Classification Namecatheter, coronary, atherectomy
Generic Nameatherectomy system
ApplicantBOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
PMA NumberP910019
Supplement NumberS003
Date Received10/28/1997
Decision Date01/29/1998
Product Code
MCX[ Registered Establishments with MCX ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the 5. 5f tec(r) cutter catheter, involving an increase in the skirt length of the cutter component from 0. 079 inches to 0. 104 inches.
-
-