PMA P940008S006

Device: RES-Q(TM) MICRON ICD SYSTEM
Applicant: Boston Scientific
PMA number: P940008
Supplement: S006
Decision date: 1997-08-13
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.

Current openFDA PMA Record

Device: RES-Q(TM) MICRON ICD SYSTEM
Applicant: Boston Scientific
PMA number: P940008
Supplement: S006
Decision date: 1997-08-13
Decision code: APPR
Date received: 1997-07-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.