PMA P010003S015
- Device
- BIOGLUE SURGICAL ADHESIVE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S015
- Product code
- MUQ
- Decision date
- 2010-05-12
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- APPROVAL FOR CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU).
Current openFDA PMA Record#
- Device
- BIOGLUE SURGICAL ADHESIVE
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S015
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2010-05-12
- Decision code
- APPR
- Date received
- 2010-04-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU).