ATS MECHANICAL HEART VALVES
FDA premarket approval P990046/S018 · decided 2008-09-11
Approval details
- PMA number
- P990046
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATS MECHANICAL HEART VALVES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2007-11-28
- Decision date
- 2008-09-11
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGING THE STERILE PRODUCT RELEASE PROCESS.
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