|
Device | CONTAK RENEWAL FAMILY |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S057 |
Date Received | 07/12/2005 |
Decision Date | 07/27/2005 |
Product Code |
LWP |
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 1) AN ALTERNATE MAGNETIC REED SWITCH MANUFACTURED BY HERMETIC AND AN ASSOCIATED CHANGE TO THE EQUIPMENT USED IN THE REWORK OF THE COMPONENT; AND 2) PROGRAMMER SOFTWARE APPLICATION MODEL 2845 V2.8. |