- Device
- INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S107
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.