Only a six-month
extension is granted (through October 1988), in view of FDA's
failure to provide an adequate response to prior conditions of
approval.
Inventory as of this Action
Requested
Previously Approved
10/31/1988
10/31/1988
5,000
0
0
78,000
0
0
0
0
0
MANUFACTURER'S WISHING TO DISTRIBUTE
NE OR CHANGED MEDICAL DEVICES MUST SUBMIT A PREMARKET NOTIFICATION
TO FDA 90 DAYS BEFORE MARKETING. FDA REVIEWS THE NOTIFICATION AND
DETERMINES WHETHER THE PRODUCT IS SUBSTANTIALLY EQUIVALENT TO A
PRE-AMENDMENTS DEVICE. THOSE WHICH ARE EQUIVALENT MAY BE MARKETED
IMMEDIATELY, AND THOSE WHICH ARE NOT, MAY NOT BE MARKETED WITHOUT
FURTHER EVALUATIO
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.