PMA P240027S005
- Device
- SpineSeal Spine Sealant
- Applicant
- Pramand, LLC
- PMA number
- P240027
- Supplement
- S005
- Product code
- NQR
- Decision date
- 2026-04-01
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- a change to remove visible particulates prior to final packaging
Current openFDA PMA Record#
- Device
- SpineSeal Spine Sealant
- Applicant
- Pramand, LLC
- PMA number
- P240027
- Supplement
- S005
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to remove visible particulates prior to final packaging