PMA N970003S245
- Device
- Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S245
- Product code
- LWP
- Decision date
- 2019-11-27
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Replace the current Automated Optical Inspection equipment system and to update the inspection process.
Current openFDA PMA Record#
- Device
- Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S245
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-11-27
- Decision code
- OK30
- Date received
- 2019-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the current Automated Optical Inspection equipment system and to update the inspection process.