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 | CELCIUS DS CATHETER,NAVISTAR DS CATHETER,NAVISTAR RMT DS CATHETER,EZ STEER NAV DS CATHETER, |
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 | S035 |
Date Received | 08/09/2013 |
Decision Date | 09/05/2013 |
Product Code |
OAD |
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 INCREASING THE RANGE OF THE FINAL CHAMBER TEMPERATURE DURING DYNAMIC CONDITIONING, LOWERING THE MINIMUM LOAD TEMPERATURE DURING THE ETHYLENE OXIDE (EO) DWELL PHASE, AND CHANGING OF THE MEASUREMENT PERIOD WHEN MEASURING EO CONCENTRATION DURING THE EO DWELL PHASE. |
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