|
Device | HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1) |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S078 |
Date Received | 04/14/2005 |
Decision Date | 05/24/2005 |
Product Code |
DXY |
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 THE SOFTWARE MODIFICATIONS TO THE ST. JUDE MEDICAL HOUSECALL PLUS RECEIVER SOFTWARE (VERSION 2.1). |