BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES
FDA premarket approval P780007/S043 · decided 2003-09-12
Approval details
- PMA number
- P780007
- Supplement
- S043
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2003-01-10
- Decision date
- 2003-09-12
- Days to decision
- 245 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT OCULAR SCIENCES, ALBUQUERQUE, NEW MEXICO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.