PMA P030032S014
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S014
- Product code
- LMH
- Decision date
- 2012-05-03
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.
Current openFDA PMA Record#
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S014
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2012-05-03
- Decision code
- APPR
- Date received
- 2011-12-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.