PMA P030032S016
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S016
- Product code
- LMH
- Decision date
- 2014-08-06
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.
Current openFDA PMA Record#
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S016
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-08-06
- Decision code
- APPR
- Date received
- 2013-09-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE QUALITY CONTROL TEST METHODS.