SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : PLSIA (Premier Laser Systems) -- Ignore unavailable to you. Want to Upgrade?


To: Pluvia who wrote (1690)11/3/1998 11:35:00 AM
From: Mama Bear  Read Replies (1) | Respond to of 1773
 
Pluvia, did you notice that 'Westerfraud' <g> called me 'a soulmate of Pluvia's' in #1688? I guess he missed all the posts I made when I was long (and wrong) on the B warrants.

Caveat Emptor,

Barb



To: Pluvia who wrote (1690)11/4/1998 6:07:00 AM
From: Westergaard  Respond to of 1773
 
Hey, Pluvia, thanks for the heads up on the FDA letter. That's very helpful. Indeed, the irony is that you will never know and could not imagine how meaningfully helpful your activities relating to me and and to Westergaard Online have been in general over the past year.

Where on earth, however, do get the idea that the FDA letter to PLSIA concerns "deceptive selling practices" and problems with "reporting of injuries"? It simply reminds the company to be sure to maintain proper records of any complaints. It states that the company's responses to this matter have been "adequate" but that it should expect there to be a "reinspection" of its procedures. So what else is new???

True, the letter does remind us, in reciting various FDA regulations, that under CFR 21, 803.50(a) the company is required to advise the FDA within 30 days of learning of a patient death related to the use of its equipment. That seems eminently sensible. If I had written that particular regulation, I would have said 24 hours. How about 20 minutes?

Hmmm..... Amazing, amazing. Sir, your continuing efforts at disinformation in respect to PLSIA will be answered at every turn. How's your laser business doing, by the way? Still got those machines in inventory?