PMA P040013S003
- Device
- GEM 21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S003
- Product code
- NPZ
- Decision date
- 2006-09-22
- Classification
- Bone Grafting Material, Dental, With Biologic Component
- Generic name
- Bone grafting material, dental, with biologic component
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NOVARTIS CORPORATION, VACAVILLE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- GEM 21S
- Applicant
- Lynch Biologics, LLC
- PMA number
- P040013
- Supplement
- S003
- Product code
- NPZ
- Generic name
- Bone grafting material, dental, with biologic component
- Decision date
- 2006-09-22
- Decision code
- APPR
- Date received
- 2006-04-06
- 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 NOVARTIS CORPORATION, VACAVILLE, CALIFORNIA.