PROGEL Pleural Air Leak Sealant (PALS)
FDA premarket approval P010047/S053 · decided 2018-02-01
Approval details
- PMA number
- P010047
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGEL Pleural Air Leak Sealant (PALS)
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2018-01-04
- Decision date
- 2018-02-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change to the acceptance testing of the outer pouch used to package the extended tip accessory
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