LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
FDA premarket approval P960019/S002 · decided 1998-05-05
Approval details
- PMA number
- P960019
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
- Generic name
- Excimer laser system
- Applicant
- Laser Vision Centers, Inc.
- Date received
- 1998-04-17
- Decision date
- 1998-05-05
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK. The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.