PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP
FDA premarket approval P010047/S037 · decided 2015-03-16
Approval details
- PMA number
- P010047
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2015-03-02
- Decision date
- 2015-03-16
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO EXTEND ENROLLMENT BY 13 MONTHS TO COMPLETE ENROLLMENT IN THE PAS TO THE POST-APPROVAL STUDY PROTOCOL.
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