PMA P240027
- Device
- SpineSeal™ Spine Sealant
- Applicant
- Pramand, LLC
- Product code
- NQR
- Decision date
- 2026-09-11
- Generic name
- Sealant, dural
- Approval order statement
- Approval to decrease the lower specification limit for product swelling.
Current openFDA PMA Record#
- Device
- SpineSeal™ Spine Sealant
- Applicant
- Pramand, LLC
- PMA number
- P240027
- Supplement
- S007
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2026-09-11
- Decision code
- APPR
- Date received
- 2026-06-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to decrease the lower specification limit for product swelling.