|
Device | ISOFLEX FAMILY OF LEADS (1944,1948) |
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 | P960030 |
Supplement Number | S038 |
Date Received | 09/05/2013 |
Decision Date | 10/02/2013 |
Product Code |
NVN |
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 IMPLEMENTATION OF AN AUTOMATED LEAD TESTER (ALT) DURING MANUFACTURING OF THE LEAD FAMILIES. |