AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY
FDA premarket approval P800002/S015 · decided 2005-10-06
Approval details
- PMA number
- P800002
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2005-09-08
- Decision date
- 2005-10-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- MANUFACTURING PROCESS CHANGES FOR THE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILIES OF DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.