NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S010 · decided 2011-12-21
Approval details
- PMA number
- P010047
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2011-01-28
- Decision date
- 2011-12-21
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE PROGEL APPLICATOR EXTENDED SPRAY TIPS AS AN ACCESSORY FOR THE PROGEL PLEURAL AIR LEAK SEALANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROGEL APPLICATOR EXTENDED SPRAY TIPS AND THE INDICATIONS FOR USE IS 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
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