PMA P930021S003

Device: EMDOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S003
Product code: NQA
Decision date: 1999-08-24
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: Approval for packaging changes for EMDOGAIN(R). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.

Current openFDA PMA Record#

Device: EMDOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S003
Product code: NQA
Generic name: Biologic material, dental
Decision date: 1999-08-24
Decision code: APPR
Date received: 1999-05-20
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for packaging changes for EMDOGAIN(R). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.