|
Device | CURRENT RF AND PROMOTE RF FAMILY OF DEVICES |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S195 |
Date Received | 11/24/2008 |
Decision Date | 12/23/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE HEADER COMPONENT ON ALL ST. JUDE MEDICAL CURRENT RF AND PROMOTE (UNITY) FAMILY DEVICES. |