PMA P120021S023
- Device
- AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P120021
- Supplement
- S023
- Product code
- MLV
- Decision date
- 2021-12-22
- Generic name
- Transcatheter septal occluder
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P120021
- Supplement
- S023
- Product code
- MLV
- Generic name
- Transcatheter septal occluder
- Decision date
- 2021-12-22
- Decision code
- APPR
- Date received
- 2021-11-26
- 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.