PMA approvals

SpineSeal Spine Sealant

Pramand, LLC · Sealant, dural · Neurology

P240027Original PMAApproved
Open FDA's page for this record
PMA number
P240027
Applicant
Pramand, LLC
Street 1
201 Burlington Rd., Suite 210
City
Bedford
State
MA
Zip
02420
Generic name
Sealant, dural
Trade name
SpineSeal Spine Sealant
Product code
NQR
Advisory committee
NE
Advisory committee description
Neurology
Expedited review flag
N
Date received
2024-08-19
Decision date
2025-02-14
Docket number
25M-0438
Fed reg notice date
2025-02-21
Decision code
APPR
Ao statement
The SpineSeal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
Harmonized identifiers (openFDA)
Device name
Sealant, Dural
Medical specialty description
Unknown
Device class
3
Registration number
8010177, 3003418325, 3010291427, 3012102437, 1424263, 1219930, 3018094310, 3009882464, 3043624366, 2030598, 3013820501, 3016980830, 3035387162, 3012507533, 3005920920
FEI number
3003418325, 3010291427, 3012102437, 3003015552, 1219930, 3018094310, 3009882464, 3043624366, 3002821504, 3013820501, 3016980830, 3035387162, 3012507533, 1000518731, 3005920920
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.