- Device
- L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S303
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies