PMA P910073S156
- Device
- RELIANCE 4-FRONT Steroid Eluting Leads
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S156
- Product code
- LWS
- Decision date
- 2019-06-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Updates to potency and elution acceptance criteria for finished leads.
Current openFDA PMA Record#
- Device
- RELIANCE 4-FRONT Steroid Eluting Leads
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S156
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-06-19
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to potency and elution acceptance criteria for finished leads.