PMA P100030S011
- Device
- PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S011
- Product code
- NBE
- Decision date
- 2017-08-30
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Use of two roller bottles for each of the syringe’s solutions into the filler machine.
Current openFDA PMA Record#
- Device
- PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S011
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2017-08-30
- Decision code
- OK30
- Date received
- 2017-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of two roller bottles for each of the syringe’s solutions into the filler machine.