Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | Enterra Therapy System |
Classification Name | intestinal stimulator |
Generic Name | intestinal stimulator |
Applicant |
Enterra Medical, Inc. |
5353 wayzata blvd. |
suite 400 |
st. louis park, MN 55416 |
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HDE Number | H990014 |
Supplement Number | S139 |
Date Received | 09/07/2017 |
Decision Date | 12/28/2017 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its evaluation of your premarket approval application (pma) supplement, which requested approval for a manufacturing site located at medtronic puerto rico operations complany, villabla, road 149, kilometer 56. 3, call box 6001, villalba, puerto rico. Based upon the information submitted, the pma supplement is approved. You may begin commercial distribution of the device as modified by your pma supplement in accordance with the conditions described below. Continued approval of this pma is contingent upon the submission of periodic post-approval reports required under 21 cfr 814. 84, at intervals of one year (unless otherwise specified) from the date of approval of the original pma. Two copies of this report, identified as "annual report" (please use this title even if the specified interval is more frequent than one year) and bearing the applicable pma reference number, should be submitted to the address below. The annual report should indicate the beginning and ending date of the period covered by the report and should include the information required by 21 cfr 814. 84. |
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