PMA P050044S018
- Device
- AUTOMATED WASHER
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S018
- Product code
- LMF
- Decision date
- 2011-07-26
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- USE OF AN AUTOMATED WASHER AS AN ALTERNATIVE TO MANUAL CLEANING OF EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL SURGICAL HEMOSTAT.
Current openFDA PMA Record#
- Device
- AUTOMATED WASHER
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S018
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2011-07-26
- Decision code
- OK30
- Date received
- 2011-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN AUTOMATED WASHER AS AN ALTERNATIVE TO MANUAL CLEANING OF EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL SURGICAL HEMOSTAT.