|
Device | FLEXTOME CUTTING BALLOON MONORAIL |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S019 |
Date Received | 09/19/2006 |
Decision Date | 10/19/2006 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN THE STERILITY DOSE AUDIT PROCEDURES FROM VD MAX TO METHOD 1, WITH CORRESPONDING CHANGES IN MINIMUM RADIATION STERILIZATION DOSE AND THE NUMBER OF QUARTERLY STERILIZATION DOSE AUDITS. |