Implantable Pulse Generator Test Magnet
FDA premarket approval P830060/S084 · decided 2021-04-16
Approval details
- PMA number
- P830060
- Supplement
- S084
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Pulse Generator Test Magnet
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Boston Scientific
- Date received
- 2021-02-24
- Decision date
- 2021-04-16
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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