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 NameNIR(R) PREMOUNTED STENT DELIVERY SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS029
Date Received02/27/2001
Decision Date03/27/2001
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from an internal particulate maximum level to an internal particulate action level of 75,000 particles >=10 microns for the finished product.
-
-