PMA P150012S011
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S011
- Product code
- LWP
- Decision date
- 2016-08-02
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to the molding manufacturing line.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI PACEMAKER'S
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S011
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-08-02
- Decision code
- OK30
- Date received
- 2016-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the molding manufacturing line.