AMPLATZER DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE)
FDA premarket approval P020024/S034 · decided 2011-10-21
Approval details
- PMA number
- P020024
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE)
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-09-20
- Decision date
- 2011-10-21
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE THE CURRENT SEAL TEST METHOD FROM MANUAL TO SEMIAUTOMATIC.
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