PIPLINE TM EMBOLIZATION DEVICE
FDA premarket approval P100018/S006 · decided 2013-04-02
Approval details
- PMA number
- P100018
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Trade name
- PIPLINE TM EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2013-03-12
- Decision date
- 2013-04-02
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE THE SOFTWARE USED TO GENERATE PRINTED WORK ORDERS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.