STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
FDA premarket approval P930021/S013 · decided 2013-07-02
Approval details
- PMA number
- P930021
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2012-09-19
- Decision date
- 2013-07-02
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDEON SCIENCE PARK, MALMO, SWEDEN.
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