COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM
FDA premarket approval P810006/S043 · decided 2013-06-26
Approval details
- PMA number
- P810006
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-05-28
- Decision date
- 2013-06-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- REPLACEMENT OF AIR HANDLING UNITS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.