|
Device | FLEXTOME CORONARY 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 | S031 |
Date Received | 12/17/2008 |
Decision Date | 01/14/2009 |
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 TO THE VENDOR FOR THE OVER-THE-WIRE (OTW) MANIFOLD COMPONENT USED TO MANUFACTURE THE FLEXTOME CORONARY CUTTING BALLOON. |