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.
 
DeviceMEDTRONIC GEM III AT MODEL 7276 (ICD)
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St.
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980050
Supplement NumberS002
Date Received11/06/2000
Decision Date02/13/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC GEM III AT MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH THE MODEL 9465 PATIENT ASSISTANT.
-
-