WASHINGTON, March 16 (Reuters) - U.S. Food and Drug Administration staff, in documents released on Tuesday, said:
* Medtronic study of REVO MRI SureScan Pacing System met all
objectives
* Medtronic study of REVO MRI pacing system had 'several important
limitations'
* Medtronic study was 'modest in size,' 'had a substantial amount
of missing data'
* Agency views Medtronic study design 'as one intended to be
confirmatory to more comprehensive preclinical testing'
* Agency will ask advisory panel on Friday to comment on appropriateness of
Medtronic study design and quality of results
(Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Medtronic study of REVO MRI SureScan Pacing System met all
objectives
* Medtronic study of REVO MRI pacing system had 'several important
limitations'
* Medtronic study was 'modest in size,' 'had a substantial amount
of missing data'
* Agency views Medtronic study design 'as one intended to be
confirmatory to more comprehensive preclinical testing'
* Agency will ask advisory panel on Friday to comment on appropriateness of
Medtronic study design and quality of results
(Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.