PMA P150012S020
- Device
- ESSENTIO MRI Models L110, L111, L131;
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S020
- Product code
- LWP
- Decision date
- 2016-12-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI Models L110, L111, L131;
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S020
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-12-12
- Decision code
- OK30
- Date received
- 2016-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.