PMA P830060S039
- Device
- MODEL 0010 BIPOLAR ENDOCARDIAL LEAD
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S039
- Product code
- LWS
- Decision date
- 1995-08-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE MODEL 0010 LEAD AND TO USE A "TRAY-IN-TRAY" PACKAGING SYSTEM FRO THE LEAD
Current openFDA PMA Record#
- Device
- MODEL 0010 BIPOLAR ENDOCARDIAL LEAD
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S039
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1995-08-28
- Decision code
- APPR
- Date received
- 1995-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE MODEL 0010 LEAD AND TO USE A "TRAY-IN-TRAY" PACKAGING SYSTEM FRO THE LEAD