AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT- ENDOAVITENE 5 MM
FDA premarket approval P800002/S020 · decided 2014-01-14
Approval details
- PMA number
- P800002
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT- ENDOAVITENE 5 MM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2013-12-11
- Decision date
- 2014-01-14
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- ADD A NEW SUPPLIER FOR THE BLISTER TRAY USED FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT-ENDO AVITENE PRODUCT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.