|
Device | CORONARY FLEXTOME CUTTING BALLOON DEVICE |
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 | S030 |
Date Received | 09/05/2008 |
Decision Date | 10/01/2008 |
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 ADDITION OF A STEP TO AN EXISTING IN-PROCESS INSPECTION OF THE PROXIMAL BALLOON BOND FOR ALL MODELS OF THE DEVICE. |