PMA P940008S004
- Device
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S004
- Decision date
- 1997-02-28
- Approval order statement
- APPROVAL FOR A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RES-Q(TM) MICRON MODEL 101-09 AND MDOEL 101-05
Current openFDA PMA Record
- Device
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S004
- Decision date
- 1997-02-28
- Decision code
- APPR
- Date received
- 1996-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RES-Q(TM) MICRON MODEL 101-09 AND MDOEL 101-05