PMA P930021S006
- Device
- EMDOGAIN GEL
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S006
- Product code
- NQA
- Decision date
- 2003-03-28
- Classification
- Biologic Material, Dental
- Generic name
- Biologic material, dental
- Approval order statement
- APPROVAL FOR EXTENSION OF THE EXPIRATION DATE ON EMDOGAIN GEL FROM 18 MONTHS TO 24 MONTHS.
Current openFDA PMA Record#
- Device
- EMDOGAIN GEL
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S006
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2003-03-28
- Decision code
- APPR
- Date received
- 2002-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENSION OF THE EXPIRATION DATE ON EMDOGAIN GEL FROM 18 MONTHS TO 24 MONTHS.