AMPLATZER SEPTAL OCCLUDER AND AMPLATZER EXCHANGE SYSTEM
FDA premarket approval P000039/S035 · decided 2010-04-22
Approval details
- PMA number
- P000039
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER SEPTAL OCCLUDER AND AMPLATZER EXCHANGE SYSTEM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-03-11
- Decision date
- 2010-04-22
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.
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