PMA P910073S145
- Device
- Reliance 4- Front Lead Family and Suture Sleeve Accessory
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S145
- Product code
- LWS
- Decision date
- 2018-05-04
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the RELIANCE 4-FRONT lead family and suture sleeve accessory (Model 6403).
Current openFDA PMA Record#
- Device
- Reliance 4- Front Lead Family and Suture Sleeve Accessory
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S145
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-05-04
- Decision code
- APPR
- Date received
- 2017-12-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the RELIANCE 4-FRONT lead family and suture sleeve accessory (Model 6403).