PMA P140033S055
- Device
- Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S055
- Decision date
- 2020-02-28
- Approval order statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.
Current openFDA PMA Record#
- Device
- Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S055
- Decision date
- 2020-02-28
- Decision code
- OK30
- Date received
- 2020-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adopt sterilization recipe Cycle PG 600 for the Abbott Penang Malaysia manufacturing facility.