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 | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
Generic Name | Computer-assisted personalized sedation system |
Applicant | Scott Laboratories, Inc 2804 N. Loop 289 Lubbock, TX 79415 |
PMA Number | P080009 |
Supplement Number | S001 |
Date Received | 06/27/2013 |
Decision Date | 06/16/2014 |
Product Code |
PDR |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN MODIFICATIONS TO THE HARDWARE, FIRMWARE, AND SOFTWARE AND A NEW MANUFACTURING FACILITY AT FLEX MEDICAL IN TIJUANA, MEXICO. |
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