|
Device | TENDRILL SDX LEAD MODELS 1488T/1488TC |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S023 |
Date Received | 09/29/2006 |
Decision Date | 12/05/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW 3-GROOVE SUTURE SLEEVE DESIGN FOR THE TENDRIL SDX LEAD MODELS 1488T AND 1488TC. |