Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT )
FDA premarket approval P100029/S035 · decided 2018-09-10
Approval details
- PMA number
- P100029
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT )
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-08-13
- Decision date
- 2018-09-10
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for labeling changes implemented to provide safety information regarding future valve in valve implantations.
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