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.
 
DeviceENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS031
Date Received01/14/2000
Decision Date04/11/2000
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an extra lead port to the the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049 and a modified DF-1 terminal of: the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049; ENDOTAK SQ Patch Lead Model 0047; ENDOTAK SQ Array Subcutaneous Lead Model 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
-
-