Tridyne Vascular Sealent
FDA premarket approval P150016/S015 · decided 2018-07-26
Approval details
- PMA number
- P150016
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tridyne Vascular Sealent
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2018-06-27
- Decision date
- 2018-07-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Change to the radiation dose used for the sterile Nalgene plastic containers used to store and deliver the Polyethylene Glycol Disuccinimidyl Succinate (PEG(SS)2) raw material to Neomend.
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