STAT PACE II
FDA premarket approval P840002/S011 · decided 2004-10-01
Approval details
- PMA number
- P840002
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- STAT PACE II
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 2004-03-09
- Decision date
- 2004-10-01
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.