PMA P880098S010
- Device
- MENICON SF-P (MELAFOCON A) CONTACT LENS
- Applicant
- Menicon Co, Ltd.
- PMA number
- P880098
- Supplement
- S010
- Product code
- LPM
- Decision date
- 1997-08-25
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval for an alternate packaging process where Barnes Hind(R) Comfort Care(R) GP Wetting and Soaking Solution is added to the lens shipping case. Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration.
Current openFDA PMA Record#
- Device
- MENICON SF-P (MELAFOCON A) CONTACT LENS
- Applicant
- Menicon Co, Ltd.
- PMA number
- P880098
- Supplement
- S010
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 1997-08-25
- Decision code
- APPR
- Date received
- 1997-06-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for an alternate packaging process where Barnes Hind(R) Comfort Care(R) GP Wetting and Soaking Solution is added to the lens shipping case. Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration.