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. |
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Device | NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P010068 |
Supplement Number | S020 |
Date Received | 03/02/2010 |
Decision Date | 10/01/2010 |
Product Code |
OAD |
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 STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO. |
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