PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S024 · decided 2012-12-07
Approval details
- PMA number
- P010047
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-10-11
- Decision date
- 2012-12-07
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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