- Device
- COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S038
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2013-06-10
- Decision code
- OK30
- Date received
- 2013-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF SAMPLING PLAN ANALYZER SOFTWARE.