|
Device | STELID II BFT/BJF/STELIX BR/STELIX II BRF |
Generic Name | Permanent defibrillator electrodes |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P020030 |
Supplement Number | S008 |
Date Received | 02/28/2011 |
Decision Date | 03/31/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPDATE TO THE CURRENT LEADS LABEL PRINTING SOFTWARE. |