|
Device | THERAPY COOL PATH CARDIAC ABLATION CATHETER AND 1500T9 CARDIAC ABLATION GENERATOR |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P060019 |
Supplement Number | S003 |
Date Received | 06/07/2007 |
Decision Date | 07/26/2007 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR DESIGN CHANGE WHICH ADDED A VOLUME CONTROL TO THE AUDIBLE OUTPUT DEVICE TO PERMIT THE USER TO VARY THE VOLUME OF THE CONTINUOUS BEEPING SOUND MADE DURING RADIOFREQUENCY DELIVERY OF POWER. |