|
Device | MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 3576 UNO CAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P870036 |
Supplement Number | S040 |
Date Received | 09/19/1996 |
Decision Date | 10/25/1996 |
Withdrawal Date
|
06/09/2008 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR THE MEDTRONIC(R) FALCON(R) FAMILY OF CORONARY BALLOON DILATATION CATHETERS |