EMS-SWISS DOLORCLAST
FDA premarket approval P050004/S001 · decided 2009-08-28
Approval details
- PMA number
- P050004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMS-SWISS DOLORCLAST
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Electro Medical Systems (Ems Sa)
- Date received
- 2009-02-25
- Decision date
- 2009-08-28
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Nyon
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT E.M.S. ELECTRO MEDICAL SYSTEMS, SA, NYON, SWITZERLAND.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PIEZON MASTER 400 (K896749) | Electro Medical Systems (Ems Sa) | 1990-08-31 |
| AIR FLOW SII (K900709) | Electro Medical Systems (Ems Sa) | 1990-04-18 |