- Device
- RELIANCE™ S Passive Single Coil, RELIANCE S Active Fix Single Coil, RELIANCE Passive Dual Coil, RELIANCE Active Fix Dual
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S192
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-06-09
- Decision code
- OK30
- Date received
- 2026-05-11
- 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 Brooklyn Park