|
Device | FOCAL CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S056 |
Date Received | 06/23/2014 |
Decision Date | 07/09/2014 |
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 ADDITION OF AN INSPECTION PROCEDURE FOR THE LOW PRESSURE REGULATOR DURING MANUFACTURING, AS WELL AS THE REPLACEMENT OF AN ANALOG PRESSURE GAUGE USED DURING INSTALLATION AND MAINTENANCE WITH A DIGITAL ONE. |