PMA P030032S017
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S017
- Product code
- LMH
- Decision date
- 2014-09-05
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- ADDITION OF ENDOTOXIN TESTING TO THE PURIFIED WATER RAW MATERIAL SPECIFICATION.
Current openFDA PMA Record#
- Device
- PREVELLE SILK
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S017
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2014-09-05
- Decision code
- OK30
- Date received
- 2014-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF ENDOTOXIN TESTING TO THE PURIFIED WATER RAW MATERIAL SPECIFICATION.