PMA P100030S010
- Device
- PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S010
- Product code
- NBE
- Decision date
- 2017-08-21
- Generic name
- Sealant, polymerizing
- Approval order statement
- Use of an alternative 10-pack shipping case.
Current openFDA PMA Record#
- Device
- PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S010
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2017-08-21
- Decision code
- OK30
- Date received
- 2017-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternative 10-pack shipping case.