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.
 
DeviceBOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
Generic NamePULSE-GENERATOR, PROGRAM MODULE
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880065
Supplement NumberS006
Date Received07/12/2001
Decision Date07/30/2001
Withdrawal Date 09/20/2007
Product Code LOT 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
-
-