|
Device | SDX PERMANENT PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S014 |
Date Received | 10/24/2005 |
Decision Date | 06/08/2006 |
Product Codes |
NVY NVZ |
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 REDUCTION IN THE HUMIDITY OVEN CURE-TIME FOR SJM LEADS. |