|
Device | SCIMED RADIUS CORONARY STENT |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S007 |
Date Received | 04/20/1999 |
Decision Date | 09/17/1999 |
Withdrawal Date
|
07/17/2007 |
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 the addition of a centerless grinding process to widen trace element nitinol tubing material. |