PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S022 · decided 2013-04-04
Approval details
- PMA number
- P010047
- Supplement
- S022
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-08-20
- Decision date
- 2013-04-04
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGE TO A RESIN SUPPLIER.
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