PMA P940008S008
- Device
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S008
- Decision date
- 1997-12-29
- Approval order statement
- Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.
Current openFDA PMA Record
- Device
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S008
- Decision date
- 1997-12-29
- Decision code
- APPR
- Date received
- 1997-11-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.