MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S003 · decided 1982-09-22
Approval details
- PMA number
- P790018
- Supplement
- S003
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1982-07-29
- Decision date
- 1982-09-22
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, 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.