|
Device | VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S069 |
Date Received | 08/04/2005 |
Decision Date | 09/21/2005 |
Product Codes |
KRG LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES. |