PMA P150012S066
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S066
- Product code
- LWP
- Decision date
- 2018-11-16
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.
Current openFDA PMA Record#
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S066
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-11-16
- Decision code
- OK30
- Date received
- 2018-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.