HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
FDA premarket approval P870011 · decided 1990-09-06
Approval details
- PMA number
- P870011
- Trade name
- HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Towers Perrin
- Date received
- 1987-02-27
- Decision date
- 1990-09-06
- Days to decision
- 1287 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.