PASG are an approved treatment modality classified as pre-amendment devices under FDA regulations and have been extensively marketed and used for pelvic bleeding, so it was deemed to be impossible and unethical to prohibit use as a last resort in the clinical setting.
If your device falls under Class III, you will be required a Pre-market Approval or PMA unless it is a pre-amendments device (which means on the market before the medical device amendments passage in 1976 or an equivalent device).
These include defensive charter amendments and other devices bearing some rather exotic, but apt, names: Crown Jewel, White Knight, Pac Man, and Golden Parachute.
Although the appeal will most likely turn on the Supreme Court's interpretation of the 1976 medical devices amendments to the Food, Drug and Cosmetic Act, the case is part of a broader debate in Washington over the extent to which the Bush administration and Congress may preclude the states from imposing consumer regulations that are more stringent than the federal government's.
Surveillance findings can lead to the re-assessment of a risk, improvements in the design of the device, or amendments in the instructions for use.
Both airlines fly to gambling's galactic HQ, Las Vegas, but a US law known as the Gorton Amendment prohibits "any gambling device" to be fitted to jets using American airspace.
The medical devices amendment forbids a state from adopting any requirement "which is different from, or in addition to, any requirement" in federal law.
The new user fee agreements (the Prescription Drug User Fee Act and Medical Device User Fee Amendments) are moving issues forward, but nothing can replace solid support, in words and deeds.
Third, the amendment calls for a legal device called "rebuttable presumption".
Mr Lott's device is an amendment to the bill that would ban unions from making political contributions from their members' and non-members' dues without their prior permission.
In his first speech as leader, Pearson (recently returned from Oslo where he had been awarded the Nobel Peace Prize), moved an amendment to supply (a technical device whereby oppositions attempt to secure the government's resignation), and called, not for an election, but for the Progressive Conservatives to resign, allowing the Liberals to form a government.
