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. |
|
Device | CURRENT, ELLIPSE, FORTIFY, FORTIFYASSURA FAMILIES OF ICD DEVICES |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S327 |
Date Received | 01/23/2014 |
Decision Date | 02/18/2014 |
Product Code |
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 XTS ANODE FOIL ETCHING ADDITIVE FOR MANUFACTURING OF THE HIGH VOLTAGE CAPACITORS FOR THE DEVICES. |
|
|