Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990025 |
Supplement Number | S040 |
Date Received | 07/02/2014 |
Decision Date | 12/17/2015 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE. |
|
|