|
Device | SJM ACTIVE & PASSIVE LEADS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S028 |
Date Received | 02/26/2007 |
Decision Date | 11/19/2009 |
Product Code |
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 | Yes |
Approval Order Statement APPROVAL FOR A MINOR PROCESS CHANGE TO AN SJM VENDOR IN THE MANUFACTURE OF SJM ACTIVE AND PASSIVE LEADS. |