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.
 
DeviceTHINLINE/FINELINE LEADS FAMILIES
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960004
Supplement NumberS054
Date Received07/26/2012
Decision Date10/05/2012
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
-
-