PMA P140033S057
- Device
- Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S057
- Product code
- LWP
- Decision date
- 2020-05-22
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Tendril MRI
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140033
- Supplement
- S057
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-05-22
- Decision code
- APPR
- Date received
- 2020-04-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.