PMA P260019
- Device
- Amplatzer Paraclose PVL Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P260019
- Product code
- SJT
- Decision date
- 2026-10-27
- Classification
- Cardiovascular
- Generic name
- Para-device leak occluder
- Approval order statement
- The Amplatzer™ Paraclose PVL Occluder is indicated for use in patients who have developed a clinically significant paravalvular leak associated with a surgical aortic or mitral valve prosthesis.
Current openFDA PMA Record#
- Device
- Amplatzer Paraclose PVL Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P260019
- Product code
- SJT
- Generic name
- Para-device leak occluder
- Decision date
- 2026-10-27
- Decision code
- APPR
- Date received
- 2026-04-30
- Approval order statement
- The Amplatzer™ Paraclose PVL Occluder is indicated for use in patients who have developed a clinically significant paravalvular leak associated with a surgical aortic or mitral valve prosthesis.