PMA P930021S007
- Device
- EMDOGAIN GEL
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S007
- Product code
- NQA
- Decision date
- 2003-05-20
- Classification
- Biologic Material, Dental
- Generic name
- Biologic material, dental
- Approval order statement
- APPROVAL OF THE ADDITIONAL INDICATIONS FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY FOR MANDIBULAR CLASS II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS.
Current openFDA PMA Record#
- Device
- EMDOGAIN GEL
- Applicant
- The Straumann Company
- PMA number
- P930021
- Supplement
- S007
- Product code
- NQA
- Generic name
- Biologic material, dental
- Decision date
- 2003-05-20
- Decision code
- APPR
- Date received
- 2002-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF THE ADDITIONAL INDICATIONS FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY FOR MANDIBULAR CLASS II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS.