|
Device | TENDRIL LEADS |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S063 |
Date Received | 12/13/2010 |
Decision Date | 02/03/2011 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE MANUFACTURE OF SHAFT ASSEMBLIES. |