PMA P100030S001
- Device
- ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S001
- Product code
- NBE
- Decision date
- 2013-11-25
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- APPROVAL FOR THE ADDITION OF 2.5ML AND 5.0ML FILL VOLUMES TO THE EXISTING 4.0ML FILL VOLUME, USING THE SAME 5ML SYRINGE AND PACKAGING.
Current openFDA PMA Record#
- Device
- ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S001
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2013-11-25
- Decision code
- APPR
- Date received
- 2013-09-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF 2.5ML AND 5.0ML FILL VOLUMES TO THE EXISTING 4.0ML FILL VOLUME, USING THE SAME 5ML SYRINGE AND PACKAGING.