PMA P050044S012
- Device
- VITAGEL SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S012
- Product code
- LMF
- Decision date
- 2010-07-23
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOVITA, INC. IN MALVERN, PENNSYLVANIA.
Current openFDA PMA Record#
- Device
- VITAGEL SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S012
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2010-07-23
- Decision code
- APPR
- Date received
- 2010-01-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOVITA, INC. IN MALVERN, PENNSYLVANIA.