MOSIAC PORCINE BIOPROSTHESIS
FDA premarket approval P990064/S037 · decided 2011-04-15
Approval details
- PMA number
- P990064
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MOSIAC PORCINE BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc.
- Date received
- 2011-02-15
- Decision date
- 2011-04-15
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO YOUR SECONDARY AND TERTIARY PACKAGING, INCLUDING THE ADDITION OF TWO NEW MATERIALS: A TEMPERATURE INDICATOR (TO BE PLACED IN THE SECONDARY PACKAGE) AND A CLEAR END SEAL LABEL.
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