• 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.
 
DeviceSUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP110042
Supplement NumberS058
Date Received02/12/2016
Decision Date08/08/2016
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Model A219 EMBLEM MRI S-ICD as well as modifications to the Model A209 EMBLEM S-ICD, Model 3401 EMBLEM S-ICD Subcutaneous Electrode, Model 4711 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool, Model 2877 Programmer Software Application and Model 3200 EMBLEM S-ICD Programmer.
Post-Approval StudyShow Report Schedule and Study Progress
-
-