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.
 
DeviceROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
Two Scimed Pl.
Maple Grove, MN 55311
PMA NumberP900056
Supplement NumberS061
Date Received03/16/2001
Decision Date04/13/2001
Product Code MCX 
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  
CHANGE IN THE VENDOR FOR WATER FOR INJECTION (WFI) WHICH IS A COMPONENT OF THE ROTAGLIDE(TM) LUBRICANT AND IS USED IN THE ROTABLATOR SYSTEM. FRESENIUS KABI WILL PRODUCE WFI AT THEIR FACILITY IN ACCORDANCE WITH USP SPECIFICATIONS.
-
-