PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S030 · decided 2013-09-25
Approval details
- PMA number
- P010047
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2013-06-28
- Decision date
- 2013-09-25
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR REMOVAL OF THE UPPER LIMIT SEAL STRENGTH SPECIFICATION FOR THE STERILE BARRIER POUCH PACKAGING AND REPLACING IT WITH THE PEEL-OPEN VERIFICATION TEST.
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