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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceRES-Q(TM) MICRON ICD SYSTEM
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940008
Supplement NumberS006
Date Received07/25/1997
Decision Date08/13/1997
Withdrawal Date07/20/2012
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THIS SUPPLEMENT CONTAINS THE CHANGES TO A DOCUMENT THAT WAS ORIGINALLY SUBMITTED WITH THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) SUPPLEMENT APPLICATION G950212/S8. THE IDE SUPPLEMENT REQUESTED TO CLOSE THE CLINICAL INVESTIGATION OF RES-Q II ACD DEVICES. SINCE THE IDE WAS OFFICIALLY CLOSED, FDA RECOMMENDED TO USE THIS PMA SUPPLEMENT AS AN ADMINISTRATIVE VEHICLE TO ADDRESS THE DEAR DOCTOR LETTER THAT WAS PREVIOUSLY SUBMITTED AS PART OF THE IDE SUPPLEMENT. FDA ACKNOWLEDGES THAT ALTHOUGH THE ABOVE INFORMATION HAS BEEN SUBMITTED AS A SUPPLEMENT TO THIS PMA, THE RES-Q II ACD IS NOT PART OF THE FAMILY OF SULZER INTERMEDICS PMA APPROVED PRODUCTS. FDA FURTHER ACKNOWLEDGES THAT SULZER INTERMEDICS IS NOT SEEKING COMMERCIAL APPROVAL OF THE RES-Q II ACD DEVICE. BASED UPON THE INFORMATION SUBMITTED, THE PMA SUPPLEMENT IS APPROVED WITHOUT CONDITIONS.
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