|
Device | VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S086 |
Date Received | 09/26/2005 |
Decision Date | 11/10/2005 |
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 TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING. |