|
Device | PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P900043 |
Supplement Number | S021 |
Date Received | 01/11/2000 |
Decision Date | 02/04/2000 |
Withdrawal Date
|
09/02/2008 |
Product Code |
MAF |
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 (1) the addition of a note in the Instructions for Use regarding correct prepping procedures for the balloon; (2) the addition of new width and height specifications for the inflation lumen tubing, and (3) the addition of an automated deflation test prior to product release. |