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 ROTALINK EXCHANGABLE CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP900056
Supplement NumberS094
Date Received09/09/2008
Decision Date01/14/2009
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ¿ ROTALINK EXCHANGEABLE CATHETER, WHICH REVISES THE RECOMMENDED OPTIMAL ROTATIONAL SPEED RANGE FOR THE SYSTEM.
-
-