PMA P220014S001
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S001
- Product code
- NQR
- Decision date
- 2023-12-23
- Classification
- Neurology
- Generic name
- Sealant, dural
- Approval order statement
- approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220014
Current openFDA PMA Record#
- Device
- CraniSeal Dural Sealant
- Applicant
- Pramand, LLC
- PMA number
- P220014
- Supplement
- S001
- Product code
- NQR
- Generic name
- Sealant, dural
- Decision date
- 2023-12-23
- Decision code
- APPR
- Date received
- 2023-08-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220014