PMA P100030S008
- Device
- PreveLeak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S008
- Product code
- NBE
- Decision date
- 2017-12-21
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for Preveleak Surgical Sealant. The device is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100030S008B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PreveLeak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S008
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2017-12-21
- Decision code
- APPR
- Date received
- 2017-07-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Preveleak Surgical Sealant. The device is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage.