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.
 
DeviceSLS SPECTRANETICS LASER SHEATHS
Generic NameDEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
ApplicantSpectranetics (Philips)
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS032
Date Received11/30/2011
Decision Date02/17/2012
Product Code MFA 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION.
-
-