EMDOGAIN GEL
FDA premarket approval P930021/S005 · decided 2002-06-04
Approval details
- PMA number
- P930021
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EMDOGAIN GEL
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2000-07-26
- Decision date
- 2002-06-04
- Days to decision
- 678 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR THE REVISIONS TO THE PACKAGE INSERT AS LISTED BELOW BASED ON NEW DATA THAT HAS BEEN PRESENTED IN THIS PMA SUPPLEMENT. 1) INCLUSION OF THE FOLLOWING STATEMENT IN THE CLINICAL CONSIDERATIONS SECTION: "HISTOLOGICAL STUDIES HAVE DEMONSTRATED RESULTS RANGING FROM COMPLETE PERIODONTAL REGENERATION (NEWLY FORMED CEMENTUM, PERIODONTAL LIGAMENT, AND ALVEOLAR BONE) TO REPAIR INCLUDING NEW CONNECTIVE TISSUE ATTACHMENT (CONNECTIVE TISSUE ADAPTATION VIA NEW CEMENTUM) AND A NEW ATTACHMENT MEDIATE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.