KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
FDA premarket approval P850069/S003 · decided 1989-01-13
Approval details
- PMA number
- P850069
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
- Generic name
- LIGAMENTS AND TENDONS, SYNTHETIC
- Applicant
- 3M Company
- Date received
- 1988-10-19
- Decision date
- 1989-01-13
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LML
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- St. Paul, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.