|
Device | THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S045 |
Date Received | 08/14/2014 |
Decision Date | 09/12/2014 |
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 MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS QUAD LUMEN SOFT TIP. |