PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S027 · decided 2013-08-08
Approval details
- PMA number
- P010047
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2013-03-07
- Decision date
- 2013-08-08
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MODIFIED KIT ORIENTATION DURING E-BEAM STERILIZATION.
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