PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/
FDA premarket approval P010047/S039 · decided 2015-06-26
Approval details
- PMA number
- P010047
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2015-05-28
- Decision date
- 2015-06-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADD A SECOND SUPPLIER FOR THE BIOBURDEN TESTING, WHICH IS PERFORMED ON A QUARTERLY BASIS TO CONFIRM BIOBURDEN LEVELS PRIOR TO RELEASE OF THE EXTENDED APPLICATOR SPRAY TIPS FOR ETHYLENE OXIDE STERILIZATION REMAIN ACCEPTABLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.