PMA P830060S067
- Device
- VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S067
- Product code
- LWS
- Decision date
- 2011-09-01
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES.
Current openFDA PMA Record#
- Device
- VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S067
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-09-01
- Decision code
- APPR
- Date received
- 2011-03-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE TERMINAL TOOL (RENAMED EZ-4 CONNECTOR TOOL), DESIGN CHANGE TO THE LEAD AND TOOL PACKAGING, AND VARIOUS LABELING CHANGES.