- Device
- L100 ESSENTIO™ SR, L101 ESSENTIO™ DR, L121 ESSENTIO™ EL DR, L200 PROPONENT™ SR, L201 PROPONENT™ DR, L221 PROPONENT™ EL D
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S271
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-12-23
- Decision code
- OK30
- Date received
- 2021-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Re-order the low voltage pulse generator Top Attach/Test manufacturing process steps.