STRAUMANN EMDOGAIN
FDA premarket approval P930021/S012 · decided 2009-08-21
Approval details
- PMA number
- P930021
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STRAUMANN EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2009-01-12
- Decision date
- 2009-08-21
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT IBA STERIGENICS WALLONIE, S.A., IN VERVIERS, BELGIUM, FOR THE CONTRACT STERILIZATION OF THE DEVICE.
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