|
Device | THE COOL POINT IRRIGATION PUMP |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P060019 |
Supplement Number | S029 |
Date Received | 09/09/2014 |
Decision Date | 11/06/2014 |
Product Code |
LPB |
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 TO IMPLEMENT A MINOR DESIGN MODIFICATION TO THE COOL POINT IRRIGATION PUMP TO INCLUDE A PUMP PRESSURE ALARM ADAPTER AND A PRESSURE ALARM ADAPTER CABLE. |