PMA N970003S195
- Device
- INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG)
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S195
- Product code
- LWP
- Decision date
- 2016-10-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Addition of an alternate sterilization cycle for pulse generators.
Current openFDA PMA Record#
- Device
- INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG)
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S195
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-10-12
- Decision code
- OK30
- Date received
- 2016-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate sterilization cycle for pulse generators.