DURASEAL DURAL SEALANT SYSTEM
FDA premarket approval P040034/S006 · decided 2006-12-04
Approval details
- PMA number
- P040034
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASEAL DURAL SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2006-07-28
- Decision date
- 2006-12-04
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE REMOVAL OF THE FOLLOWING SENTENCE IN THE INDICATION STATEMENT: ?DURASEAL SHOULD ONLY BE USED WITH AUTOLOGOUS DURAPLASTY MATERIAL.?
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