PMA P150012S084
- Device
- MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S084
- Product code
- LWP
- Decision date
- 2019-10-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
Current openFDA PMA Record#
- Device
- MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S084
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.