PMA P930021S009
- Device
- EMDOGAIN
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S009
- Product code
- NQA
- Decision date
- 2006-04-24
- Classification
- Biologic Material, Dental
- Generic name
- Biologic material, dental
- Approval order statement
- APPROVAL FOR THE ADDITION OF POST-MARKET EXPERIENCE INFORMATION TO THE WARNING SECTION OF THE EMDOGAIN PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- EMDOGAIN
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S009
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2006-04-24
- Decision code
- APPR
- Date received
- 2006-04-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF POST-MARKET EXPERIENCE INFORMATION TO THE WARNING SECTION OF THE EMDOGAIN PACKAGE INSERT.