PMA P150012S014
- Device
- Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S014
- Product code
- LWP
- Decision date
- 2016-09-13
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to visual inspection criteria for cosmetic defects.
Current openFDA PMA Record#
- Device
- Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S014
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-09-13
- Decision code
- OK30
- Date received
- 2016-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to visual inspection criteria for cosmetic defects.