Table 1.

Summary Statistics

Premarket Applications (PMAs) - Devices: N=847 Premarket Applications (Cardiovascular Devices): N=241
	Devices		CV Devices Only
	Mean	S.D.	Mean	S.D.
Approval Time (Months)	18.12	15.84	17.31	12.96
Approval Time (First Product)	21.48	16.77	23.07	18.16
Approval Time Ratio: First Device/Average Device	1.18	1.06	1.33	1.40
Entry Order	6.37	8.79	5.06	4.32
Priority Review	0.10	0.30	0.10	0.29
New Applications (Current)	15.32	20.63	27.57	25.92
Submission Year	1994	8.46	1995	7.98
Firm	32 FEs	–	15 FEs	–
Medical Device Product Code	249 FEs	–	55 FEs	–

Summary statistics for the 847 medical devices used in the empirical analyses as well as separate descriptive statistics (right columns) for the subset of (241) cardiovascular devices alone. Approval Time measures months from PMA submission until FDA approval. Entry Order is based on the chronological ordering of PMA submissions. Priority Review is an indicator for whether a product was eligible for expedited FDA review. New Applications (Current) is a firm-specific, time-varying count of total successful new product applications that the applicant firm has completed at the time of a given submission. Submission year is the calendar year in which an application was sent to the FDA. Firm contains a set of dummy variables for each firm in the data set or a dummy indicator for being a “small” firm – i.e. one with fewer than five new applications over the entire period of observation.