|
Device | THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS) |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P060019 |
Supplement Number | S031 |
Date Received | 04/20/2015 |
Decision Date | 05/20/2015 |
Product Code |
LPB |
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 CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY. |