LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
FDA premarket approval P820009/S003 · decided 1986-09-18
Approval details
- PMA number
- P820009
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
- Generic name
- Catheter, balloon for retinal reattachment
- Applicant
- Bausch & Lomb
- Date received
- 1986-08-15
- Decision date
- 1986-09-18
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LOG
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Stellaris Elite vision enhancement system (K170052) | Bausch+Lomb | 2017-04-19 |
| Stellaris Elite Vision Enhancement System (K162342) | Bausch+Lomb | 2017-03-24 |
| STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486) | Bausch & Lomb | 2014-03-12 |
| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
| BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146) | Bausch & Lomb | 2014-01-03 |
| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |