PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S036 · decided 2015-02-13
Approval details
- PMA number
- P010047
- Supplement
- S036
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2014-07-11
- Decision date
- 2015-02-13
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE PROGEL PLEURAL AIR LEAK SEALANT (PALS). THE SINGLE USE PROGEL PLEURAL AIR LEAK SEALANT DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS INCURRED DURING RESECTION OF LUNG PARENCHYMA.
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