Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )
FDA premarket approval P100029/S034 · decided 2018-06-12
Approval details
- PMA number
- P100029
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-14
- Decision date
- 2018-06-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Addition of an alternate porcine tissue supplier.
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