- Device
- AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P020024
- Supplement
- S055
- Product code
- MAE
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Decision date
- 2019-03-05
- Decision code
- APPR
- Date received
- 2019-02-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah.