DUCT OCCLUDER
FDA premarket approval P020024/S018 · decided 2008-02-27
Approval details
- PMA number
- P020024
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUCT OCCLUDER
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-01-28
- Decision date
- 2008-02-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE TO THE LAL SAMPLE SIZE AND THE ADDITION OF A LARGER STERILIZATION CHAMBER.
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