|
Device | MENICON SF-P (MELAFOCON A) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Applicant | MENICON CO. LTD. 269A BALLARDVALE ST. WILMINGTON, MA 01887 |
PMA Number | P880098 |
Supplement Number | S010 |
Date Received | 06/30/1997 |
Decision Date | 08/25/1997 |
Withdrawal Date
|
05/05/2008 |
Product Codes |
HQD LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
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. |