• 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 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.
Classification Namestent, iliac
Generic Namestent, iliac
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP110035
Supplement NumberS019
Date Received08/29/2013
Decision Date09/27/2013
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
P050019/s0179/27/13 carotid wallstent® monorail® endoprosthesis pgsooos chilli ii® cooled ablation catheter, model8005 circucool pump, model2104 tubingkit, sterile cables boston scientific corporation maple grove mn 55311 use of new traceability/tracking software in the incoming receiving inspection area.