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.
 
DeviceSJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS098
Date Received02/02/2006
Decision Date04/05/2006
Product Code NVZ 
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 MINOR MODIFICATIONS TO THE DESIGN OF THE HIGH VOLTAGE CAPACITOR, BATTERY, FEEDTHRUS/HEADERS AND DISCRETE COMPONENTS. SPECIFICALLY, ALTERATION OF THE BATTERY PIN CONFIGURATION, MODIFICATION OF THE FEEDTHRU WIRE TUBING LENGTHS AND OF THE METHOD USED FOR APPLYING INSULATION, CHANGE IN THE VALUE OF C36 CAPACITOR FROM 10NF TO 680PF, QUALIFICATION OF AN ALTERNATE ACCELEROMETER SUBSTRATE WITH INTEGRATED RESISTOR CAPACITOR, AND THE SHIFTING OF THE ANCHOR BRIDGE TO FEEDTHRU FLANGE FROM 0.17" TO 0.18".
-
-