PMA P150012S103
- Device
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S103
- Product code
- LWP
- Decision date
- 2020-11-16
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S103
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-11-16
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.