PROGEL PLEURAL LEAK SEALANT
FDA premarket approval P010047/S016 · decided 2012-03-23
Approval details
- PMA number
- P010047
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROGEL PLEURAL LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-01-30
- Decision date
- 2012-03-23
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN EXTENSION OF SHELF LIFE OF THE PROGEL EXTENDED APPLICATOR SPRAY TIPS FORM 12 TO 24 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL EXTENDED APPLICATOR SPRAY TIPS AND IS INDICATED TO DELIVER PROGEL TO VISCERAL PLEURA DURING AN OPEN THORACOTOMY AFTER STANDARD VISCERAL PLEURAL CLOSURE (I.E. WITH SUTURES OR STAPLES) OF VISIBLE AIR LEAKS (>= 2 MM) INCURRED DURING OPEN RESECTION OF LUNG PARENCHYMA IN ADULT HUMANS BY BENDING THE MALLEABLE TIP TO DIRECT PROG
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