|
Device | CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S034 |
Date Received | 03/01/2011 |
Decision Date | 04/06/2011 |
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 A SECOND QUALIFIED CHAMBER FOR THE STERILIZATION PROCESS. |