|
Device | FLEXTOME 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 | S040 |
Date Received | 04/08/2010 |
Decision Date | 01/07/2011 |
Product Code |
LOX |
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 A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL. |