PROGEL PLEURAL AIR LEAK SEALNAT
FDA premarket approval P010047/S020 · decided 2012-05-30
Approval details
- PMA number
- P010047
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL PLEURAL AIR LEAK SEALNAT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-05-01
- Decision date
- 2012-05-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADD AN ADDITIONAL SUPPLIER FOR STERILE WATER.
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