PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S042 · decided 2016-01-26
Approval details
- PMA number
- P010047
- Supplement
- S042
- Supplement type
- 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
- 2015-12-28
- Decision date
- 2016-01-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL OF ALTERNATE SUPPLIERS OF TESTING REAGENTS USED FOR ANALYTICAL TESTING (I.E., THE BIURET TEST REAGENT AND PROTEIN PRIMARY STANDARD) OF THE TOTAL PROTEIN CONTENT OF THE HUMAN SERUM ALBUMIN (HAS) COMPONENT OF THE PROGEL PALS FINISHED DEVICE.
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