|
Device | ST.JUDE MEDICAL EPIC/ATLAS DR/VR ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S064 |
Date Received | 01/17/2003 |
Decision Date | 02/12/2003 |
Product Codes |
DXY LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE SUPPLIER FOR THE HIGH VOLTAGE CAPACITOR CATHODE MATERIAL USED FOR THE ST. JUDE MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. |