PMA P150012S028
- Device
- Essentio, Proponent, Accolade MRI.
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S028
- Product code
- LWP
- Decision date
- 2017-05-01
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modification to the software for the Automated Optical Inspection System used during header manufacturing.
Current openFDA PMA Record#
- Device
- Essentio, Proponent, Accolade MRI.
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S028
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-05-01
- Decision code
- OK30
- Date received
- 2017-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the software for the Automated Optical Inspection System used during header manufacturing.