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.
 
DevicePERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBoston Scientific
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS062
Date Received05/29/2002
Decision Date06/25/2002
Withdrawal Date04/13/2007
Product Code LOX 
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  
ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
-
-