|
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 | S001 |
Date Received | 03/30/2007 |
Decision Date | 07/13/2007 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE. |