PMA P910073S162
- Device
- RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S162
- Product code
- LWS
- Decision date
- 2021-06-08
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a visual inspection to the defibrillation lead connector terminal subassembly.
Current openFDA PMA Record#
- Device
- RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S162
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-06-08
- Decision code
- OK30
- Date received
- 2021-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a visual inspection to the defibrillation lead connector terminal subassembly.