- Device
- Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S433
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-10-26
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the minimum relative humidity from 40% to 35% in the product packaging area.