|
Device | SCIMED PTCA CATHETERS |
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 | S175 |
Date Received | 07/12/2001 |
Decision Date | 08/14/2001 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE THAT STRENGTHENS A WARNING STATEMENT INCLUDED IN THE DIRECTIONS FOR USE MANUAL. SPECIFICALLY, THE LABELING STATEMENT IS BEING MODIFIED TO EXPAND THE INFORMATION PROVIDED REGARDING THE AFFECT OF RE-PROCESSING OR RE-STERILIZATION. THE CHANGE APPLIES TO ALL DIRECTIONS FOR USE MANUALS OF CURRENTLY MARKETED PTCA CATHETERS APPROVED UNDER THIS PMA. |