- Device
- INGEVITYTM+ Lead Passive Models
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S187
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-06-01
- Decision code
- OK30
- Date received
- 2026-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove the Ethylene Oxide (EO) indicator dot and its associated post-sterilization visual inspection from the sterile packaging of the Ingevity+ Passive Leads