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.
 
DeviceAFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP880086
Supplement NumberS237
Date Received11/21/2013
Decision Date02/26/2014
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING SOFTWARE PACKAGES TO BE USED WITH THE DEVICES. THOSE SOFTWARE PACKAGES ARE:MODEL 3330 VERSION 18.1 SOFTWARE FOR THE MODEL 3650 PATIENT CARE SYSTEM (PCS) PROGRAMMER; MODEL EX2000 VERSION 7.0 REV. 1 SOFTWARE FOR MODELS EX1100 AND EX1150 MERLIN@HOME TRANSMITTERS; ANDMODEL MN5000 VERSION 7.1 SOFTWARE FOR THE MERLIN.NET SYSTEM.
Approval OrderApproval Order
-
-