|
Device | Therapy Ablation Catheters |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S031 |
Date Received | 08/12/2016 |
Decision Date | 09/08/2016 |
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 Changes to the environmental specifications and installation of data loggers for environmental monitoring. |