|
Device | PERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P860019 |
Supplement Number | S207 |
Date Received | 02/02/2006 |
Decision Date | 03/02/2006 |
Reclassified Date
|
10/08/2010 |
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 MODIFICATION OF THE EQUIPMENT NOZZLE TO THE MOLD USED FOR MAKING THE MANIFOLD OF THE ABOVE-STATED DEVICES. |