NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S001 · decided 2011-02-17
Approval details
- PMA number
- P010047
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2010-02-23
- Decision date
- 2011-02-17
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.