|
Device | HEX WRENCH(MODEL 6501) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P930035 |
Supplement Number | S011 |
Date Received | 10/30/2003 |
Decision Date | 11/21/2003 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO INCLUDE TEXT VERSIONS AND MORE DESCRIPTIVE APPLICATION DIAGRAMS FOR USING THE BI-DIRECTIONAL TORQUE WRENCH (MODEL 6942) AND HEX WRENCH (MODEL 6501). THE NEW LABELING ALSO SPECIFIED THAT THE DEVICE IS STERILIZED, NON-PYROGENIC AND SINGLE USE ONLY. |