Pre-Submission

Information Meeting

Study Risk Determination

Agreement Meeting

Determination Meeting

Submission Issue Meeting

Day 100 Meeting

Upon request

Yes

No

Yes

Yes

Yes

Yes

75 - 90 days

90 days

N/A

30 days or within time frame agreed to with sponsor

Date for meeting agreed upon within 30 days of request

21 days

100 days (from PMA filing date)

Q-Sub Type

The timeframe for meeting from receipt of submission

Meeting as method of feedback?

E-mail: info@AltaQ.com

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Washington, DC 20009

Telephone: 301.263.0544

Fax:            509.694.9964