|
Device | MICRONY FAMILY OF PACEMAKERS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S016 |
Date Received | 12/22/2006 |
Decision Date | 05/04/2007 |
Product Code |
LWO |
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 ALTERNATE AUTOMATED TEST EQUIPMENT (ATE). |