PMA P030032S009
- Device
- PREVELLE SILK & HYLAN B GEL
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S009
- Product code
- LMH
- Decision date
- 2009-10-09
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- CHANGE IN SOLUTION SAMPLING AND A CHANGE IN SILK BULK PRODUCTION.
Current openFDA PMA Record#
- Device
- PREVELLE SILK & HYLAN B GEL
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S009
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2009-10-09
- Decision code
- OK30
- Date received
- 2009-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN SOLUTION SAMPLING AND A CHANGE IN SILK BULK PRODUCTION.