PMA P150012S070
- Device
- Ingevity MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S070
- Product code
- LWP
- Decision date
- 2019-02-28
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the sales packaging and label changes being made to BSC lead families
Current openFDA PMA Record#
- Device
- Ingevity MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S070
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the sales packaging and label changes being made to BSC lead families