DURASEAL EXACT SPINE SEALANT SYSTEM
FDA premarket approval P080013/S007 · decided 2011-08-18
Approval details
- PMA number
- P080013
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURASEAL EXACT SPINE SEALANT SYSTEM
- Generic name
- Sealant, dural
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2011-07-20
- Decision date
- 2011-08-18
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR A MODIFICATION TO THE INSTRUCTIONS FOR USE TO INSTRUCT THE SURGEON IN THE BEST PRACTICES IN APPLYING THE SEALANT.
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