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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIR STENT DELIVERY SYSTEMS
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS038
Date Received08/30/2001
Decision Date09/26/2001
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATIVE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR NIR(R) AND NIROYAL(R) STENT DELIVERY SYSTEMS. THE ALTERNATIVE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON.
-
-