- Device
- ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S250
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-03-17
- Decision code
- OK30
- Date received
- 2020-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the CMS system for the monitoring of environmental conditions at the Boston Scientific Clonmel facility.