PMA P100030S019
- Device
- Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S019
- Product code
- NBE
- Decision date
- 2024-06-06
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- supplier to conduct the Dynamic Mechanical Analysis (DMA) test
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S019
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2024-06-06
- Decision code
- OK30
- Date received
- 2024-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- supplier to conduct the Dynamic Mechanical Analysis (DMA) test