|
Device | EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S056 |
Date Received | 02/20/2015 |
Decision Date | 03/19/2015 |
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 ADDITIONAL QUALIFIED SUPPLIER FOR EXTRUSION AND BRAIDING PROCESSES. |