Basic Information
- Trade Name
- RES-Q(TM) MICRON ICD SYSTEM
- PMA Number
- P940008
- Supplement Number
- S006
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 13, 1997
- Date Received
- July 25, 1997
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.