- Device
- Implantable Pulse Generator Test Magnet
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S084
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2021-04-16
- Decision code
- APPR
- Date received
- 2021-02-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Suzhou Jenitek Medical Co., Ltd. (Jenitek), No.70 Emeishan Road, SND, Suzhou, Jiangsu, China for finished device manufacturing.