THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
FDA premarket approval P000039/S060 · decided 2018-04-26
Approval details
- PMA number
- P000039
- Supplement
- S060
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
- Generic name
- Transcatheter septal occluder
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-10-30
- Decision date
- 2018-04-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MLV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for updates made to the AMPLATZER Septal Occluder Instructions for Use.
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