PMA P050052S049
- Device
- RADIESSE INJECTABLE IMPLANT
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S049
- Product code
- PKY
- Decision date
- 2015-06-04
- Classification
- Implant, Dermal, For Aesthetic Use In The Hands
- Generic name
- Implant, dermal, for aesthetic use in the hands
- Approval order statement
- APPROVAL FOR THE RADIESSE® INJECTABLE IMPLANT. THE DEVICE IS INDICATED FOR HAND AUGMENTATION TO CORRECT VOLUME LOSS IN THE DORSUM OF THE HANDS
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050052S049B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- RADIESSE INJECTABLE IMPLANT
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S049
- Product code
- PKY
- Generic name
- Implant, dermal, for aesthetic use in the hands
- Decision date
- 2015-06-04
- Decision code
- APPR
- Date received
- 2013-12-02
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE RADIESSE® INJECTABLE IMPLANT. THE DEVICE IS INDICATED FOR HAND AUGMENTATION TO CORRECT VOLUME LOSS IN THE DORSUM OF THE HANDS