AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS
FDA premarket approval P000039/S005 · decided 2003-05-13
Approval details
- PMA number
- P000039
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER SEPTAL OCCLUDER, AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2003-04-15
- Decision date
- 2003-05-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- ALTERNATE SUPPLIER FOR THE END SCREW ATTACHMENT OF THE DEVICE AS WELL AS THE DELIVERY CABLE DISTAL END SCREW, AND PROXIMAL SCREW ATTACHMENT ON THE DELIVERY CABLE.
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