|
Device | RADIUS CORONARY STENT WITH DELIVERY SYSTEM |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S008 |
Date Received | 01/24/2000 |
Decision Date | 02/11/2000 |
Withdrawal Date
|
07/17/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the addition of two tensile strenght specifications for the pullwire assembly. |