PMA P930021S013

Device: STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
Applicant: The Straumann Company
PMA number: P930021
Supplement: S013
Product code: NQA
Decision date: 2013-07-02
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDEON SCIENCE PARK, MALMO, SWEDEN.

Current openFDA PMA Record#

Device: STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
Applicant: The Straumann Company
PMA number: P930021
Supplement: S013
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2013-07-02
Decision code: APPR
Date received: 2012-09-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDEON SCIENCE PARK, MALMO, SWEDEN.