- Device
- LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S124
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-03-29
- Decision code
- OK30
- Date received
- 2022-03-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an additional inspection verification to the polyurethane tubing manufacturing process performed at the Dorado, Puerto Rico facility