MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
FDA premarket approval P970031/S007 · decided 1998-10-30
Approval details
- PMA number
- P970031
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 1998-10-02
- Decision date
- 1998-10-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- The 30-day Notice requested a change in the method in which a raw material (AOA compound) is synthesized. This will result in the raw material being received in a more purified form. The quality control test performed in incoming inspection will change from the Gravimetric test method to the Ninhydrin test method.
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