PMA P910073S171
- Device
- RELIANCE 4-FRONT
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S171
- Product code
- LWS
- Decision date
- 2023-01-16
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of a 100% Human Visual Inspection for the RELIANCE 4-FRONT lead.
Current openFDA PMA Record#
- Device
- RELIANCE 4-FRONT
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S171
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2023-01-16
- Decision code
- OK30
- Date received
- 2023-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a 100% Human Visual Inspection for the RELIANCE 4-FRONT lead.