PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S021 · decided 2012-09-05
Approval details
- PMA number
- P010047
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2012-07-12
- Decision date
- 2012-09-05
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PUSH ROD (C-00286), END CAP(C-00280) AND OUTER HOUSING (C-00279) COMPONENTS OF THE APPLICATOR KIT AND ASSOCIATED MINOR LABELING CHANGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.