PMA P140033S056
- Device
- Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S056
- Product code
- LWP
- Decision date
- 2020-03-26
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Update the dexamethasone and total impurities specification limits for annual stability testing.
Current openFDA PMA Record#
- Device
- Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S056
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-03-26
- Decision code
- OK30
- Date received
- 2020-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the dexamethasone and total impurities specification limits for annual stability testing.