PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory
FDA premarket approval P010047/S048 · decided 2017-10-12
Approval details
- PMA number
- P010047
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2017-09-07
- Decision date
- 2017-10-12
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls.
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