PMA P150012S093
- Device
- INGEVITY MRI Lead and INGEVITY non-MRI Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S093
- Product code
- LWP
- Decision date
- 2020-04-16
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add a 100% visual inspection at a supplier to detect gaps in the inner coil component.
Current openFDA PMA Record#
- Device
- INGEVITY MRI Lead and INGEVITY non-MRI Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S093
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-04-16
- Decision code
- OK30
- Date received
- 2020-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a 100% visual inspection at a supplier to detect gaps in the inner coil component.