Preveleak Surgical Sealant - 1O-Pack Delivery Tips
FDA premarket approval P100030/S014 · decided 2020-12-02
Approval details
- PMA number
- P100030
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Preveleak Surgical Sealant - 1O-Pack Delivery Tips
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2020-09-14
- Decision date
- 2020-12-02
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Updates to the labeling to reflect a change in ownership and other minor updates to conform with current labeling standards.
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