PROGEL PLEURAL AIR LEAK SEALANT
FDA premarket approval P010047/S029 · decided 2013-04-24
Approval details
- PMA number
- P010047
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Trade name
- PROGEL PLEURAL AIR LEAK SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2013-04-11
- Decision date
- 2013-04-24
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGES IN THE STERILIZATION PROCEDURES FOR THE EXTENDED TIPS AND SPARE TIPS PROVIDED WITH THE PROGEL PLEURAL AIR LEAK SEALANT KIT.
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