|
Device | VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S056 |
Date Received | 11/22/2005 |
Decision Date | 05/01/2006 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN UPDATE THE VISUAL INSPECTION CRITERIA IN GMAI (GENERAL MANUFACTURING AREA INSTRUCTION) I00093. |