|
Device | CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON) |
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 | S024 |
Date Received | 01/03/2007 |
Decision Date | 02/02/2007 |
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 |
Approval Order Statement CHANGE IN THE STERILIZATION METHOD AS WELL AS A CHANGE IN DIMENSIONS OF THE OUTER SHIPPING BOX FOR THE CUTTING BALLOON. |