PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047 · decided 2010-01-14
Approval details
- PMA number
- P010047
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2001-08-23
- Decision date
- 2010-01-14
- Days to decision
- 3066 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR PROGEL PLEURAL AIR LEAK SEALANT. THE DEVICE IS INDICATED FOR APPLICATION TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE WITH, FOR EXAMPLE, SUTURES OR STAPLES, OF VISIBLE AIR LEAKS (>=2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA.
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