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 NameROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER
Classification Namecatheter, coronary, atherectomy
ApplicantBOSTON SCIENTIFIC
PMA NumberP900056
Supplement NumberS099
Date Received03/08/2010
Decision Date08/13/2010
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) change from in-house moulding of four components to an outsourced moulding vendor; 2) a change in the moulding gate design and location; 3) change in moulding machine; and 4) change in the inspection process for the components.
-
-