PMA P010003S032
- Device
- Bioglue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S032
- Product code
- MUQ
- Decision date
- 2019-01-04
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Use an electronic system to monitor environmental conditions and equipment in the BioGlue manufacturing, quality control and raw material warehouse areas.
Current openFDA PMA Record#
- Device
- Bioglue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S032
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2019-01-04
- Decision code
- OK30
- Date received
- 2018-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an electronic system to monitor environmental conditions and equipment in the BioGlue manufacturing, quality control and raw material warehouse areas.