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.
 
DeviceANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP980037
Supplement NumberS041
Date Received02/03/2014
Decision Date03/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
MODIFICATION TO CHANGE THE CURRENT MANUAL METHOD OF QUANTIFYING THE AMOUNT OF BACTERIAL ENDOTOXINS PRESENT TO USING AN AUTOMATED INSTRUMENT. ADDITIONALLY, THE NUMBER OF SAMPLES COLLECTED WILL BE CHANGED TO THREE SAMPLES PER STERILE LOAD, TESTED ON A POOLED BASIS AND WITH EXPLICIT EXTRACTION INSTRUCTIONS.
-
-