PMA N970003S234
- Device
- ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE
- Applicant
- Boston Scientific Corp
- Product code
- LWP
- Decision date
- 2019-05-22
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for modifying the Accolade family of pacemakers and CRT-P devices
Current openFDA PMA Record#
- Device
- ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S234
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-05-22
- Decision code
- APPR
- Date received
- 2018-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifying the Accolade family of pacemakers and CRT-P devices