Senofilcon A Reactive Monomer Mix (RMM) Batches
FDA premarket approval P040045/S074 · decided 2017-06-20
Approval details
- PMA number
- P040045
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Senofilcon A Reactive Monomer Mix (RMM) Batches
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2017-05-24
- Decision date
- 2017-06-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Addition of a preliminary visual inspection screening of incoming reactive monomer mixture (RMM) batches.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.