Fw: TOXIC NEWS & VIEWS ON - CDRH PMA'S FOR AUGUST 2002]

[Guest guest]

----- Original Message ----- From: Kathi

Sent: Wednesday, September 11, 2002 8:24 PM

Subject: [Fwd: "TOXIC" NEWS & VIEWS ON - CDRH PMA'S FOR AUGUST 2002]

\"TOXIC\" News & Views wrote:

PMA Final Decisions Rendered for August 2002

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2002. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available. PMA Original Approvals

P990074/S012 8/8/02 180-Day

McGhan Saline-Filled Breast Implants

Inamed Corporation Santa Barbara, CA 93111

Approval for

design modifications to the patch configuration, changes to the patch vulcanization process, and changes to the valve vulcanization process.

P990074/S013 8/23/02 180-Day

McGhan Saline-Filled Breast Implants – Styles 68HP and 68LP

Inamed Corporation Santa Barbara, CA 93111

Approval for the addition of

Styles 68HP and 68LP and corresponding package labeling. This information provided to you by: Toxic Discovery Network 1906 Grant Lane Columbia, MO. 65203 Phone: (573) 445-8700 Fax: (573) 445-4700 www.toxicdiscovery.com "Informed Consent Begins With Informed Individuals"