SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL
FDA premarket approval P980040/S001 · decided 2001-04-18
Approval details
- PMA number
- P980040
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2001-03-08
- Decision date
- 2001-04-18
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ACRYLIC SHEET CASTING AND BUTTON FABRICATION MANUFACTURING PROCESSES TO BE PERFORMED AT A.M.O. PUERTO RICO, INC., ANASCO, PUERTO RICO.
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