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COCHLEAR LIMITED — Regulatory Filings 2008
Feb 21, 2008
64685_rns_2008-02-21_12ecc9a5-202e-42da-a3f5-86c9efe78664.pdf
Regulatory Filings
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ASX / MEDIA RELEASE 22 February 2008
COCHLEAR TO WORK WITH FDA TO RESOLVE OUTSTANDING ISSUES IN WARNING LETTER
SYDNEY: 22 February 2008
On 12 February 2008, Cochlear Limited (COH.AX) advised that it may receive a warning letter from the United States Food and Drug Administration (FDA). Cochlear Bone Anchored Solutions AB (BAS), Cochlear's Swedish subsidiary, has now received a warning letter from the FDA.
Cochlear is committed to full compliance with FDA regulations and will work with the FDA to swiftly resolve the outstanding issues.
The warning letter advises that an import alert has been issued relating to the import of Baha® products from Sweden into the USA. Inventory received into the USA prior to the import alert becoming effective can continue to be distributed. Cochlear believes that inventory already in the USA will meet customer and patient demands for the immediate future.
Contacts: Dr Chris Roberts, CEO/President Ph: (02) 9428 6555
Neville Mitchell, CFO Ph: (02) 9428 6555
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ASX Announcement / Media Release 22 February 2008
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