- Device
- RELIANCE S Active Fix Single Coil IS-1/DF-1 59cm (Model 0137); RELIANCE S Active Fix Single Coil IS-1/DF-1 64cm (Model 0
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S189
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-22
- Decision code
- OK30
- Date received
- 2026-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative vapor degreasing solvent used by a supplier, Integer Salem